Tag Archives: Levaquin

Levaquin Production Stopped by J&J/Janssen Pharmaceuticals

Janssen Pharmaceuticals, part of Johnson & Johnson, has stopped production of (brand-name) Levaquin, according to the article, “Drug maker stopped making popular antibiotic Levaquin amid concerns about mental health side effects” published on the Indianapolis ABC affiliate RTV6 The Indy Channel. Janssen/J&J stopped producing both oral and IV Levaquin in December, 2017. The discontinuation of Levaquin production was confirmed by a Janssen/J&J spokesperson who stated, “The decision to discontinue LEVAQUIN was made due to the wide availability of alternative treatment options, and our focus on developing innovative medicines designed to address unmet medical patient needs.” Though that statement is BS propaganda, it is a direct confirmation from a Janssen Pharmaceuticals spokesperson that JANSSEN/JOHNSON & JOHNSON HAS DISCONTINUED PRODUCTION OF LEVAQUIN.

THIS IS REALLY BIG NEWS! IT’S HUGE! WHOA!

LEVAQUIN HAS BEEN REMOVED FROM THE MARKET!

Unfortunately, there is still plenty of levofloxacin (generic Levaquin, made by hundreds or thousands of generic pharmaceutical producers) on the market, and it is maiming (and killing) thousands of people each year. The fight against these drugs is far from over.

Still, the removal of brand-name LEVAQUIN from the market is a really big deal, and it’s something that we, as a community, should celebrate.

We did this. All the people who filed complaints with the FDA, who testified before the FDA, EMA, and other regulatory agencies, who reached out to the press and told their stories, who shared their story of pain and suffering brought on by fluoroquinolones, all the people who shared articles about fluoroquinolone toxicity, all the scientists who did research showing the harm done by fluoroquinolones, all the advocates, all the people in the floxie community, and all the people who listened–we did this! We screamed loudly enough that people listened. Our efforts made a difference, and Janssen Pharmaceuticals has stopped making Levaquin.

“Never doubt that a small group of committed people can change the world. Indeed it is the only thing that ever has.”—Margaret Mead

I never thought that one of the pharmaceutical giants that has made billions from fluroquinolones would stop making them. Janssen Pharmaceuticals and J&J are huge–they are behemoths–and I never thought that we could move or effect them. But we did.

The efforts of everyone in the “floxie” community contributed to this outcome. We–you–should be proud.

That is my optimistic take on things. We all have an optimistic side. We all have a pessimistic side too, and here’s the bad news.

Janssen decided to stop making Levaquin because, a) their market share was small because generic levofloxacin is cheaper and widely available (“’Levaquin was only about 1 percent of the market share, and 99 percent was the generic,’ said Bennett.”), and b) they were facing significant lawsuits, and to avoid liability for the drugs they created, they pulled them from the market.

Victims of pharmaceuticals can’t sue drug-makers for harming them, they can only sue for “failure to warn” of the dangers of the drugs. This is ridiculous – I can sue you for hitting me in the face with a sledgehammer even if you warn me that you’re going to do it and that it’s going to hurt – but pharmaceutical companies aren’t held to the same standards as you or me. It’s assumed that their deadly products are mainly good and that warning of the potential for bad effects is sufficient to wash their hands of liability and responsibility. On top of that, they don’t even have to directly warn YOU, they only have to say that they warned your doctor, the “learned intermediary” of the dangers of the drugs (or, at least they have to in theory – it’s assumed that doctors actually know what’s on the warning labels for pharmaceuticals… but most don’t). Both the “failure to warn” notion and the “learned intermediary” notions are crap, and I hate them, but they’re how the system is set up.

Because victims of pharmaceuticals can only sue for “failure to warn” the door for them to sue is only open when the drug warning labels change. Fluoroquinolone warning labels have undergone significant changes in recent years. In reverse-chronological order, the following warning label changes have been added to fluoroquinolone labels:

  • In July, 2018, fluoroquinolone warning labels were changed to note that, “Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects” – Drug Safety Communication
  • In July, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together” – Drug Safety Communication
  • In May, 2016, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects” – Drug Safety Communication
  • In August, 2013, fluoroquinolone warning labels were changed to note that, “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection” – Drug Safety Communication
  • In July, 2008, fluoroquinolone warning labels were changed to note that, “FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients.” – Drug Safety Communication

With each of these warning label changes, the door opened for people to sue Janssen and Johnson & Johnson for the harm that Levaquin did to them. (It should be noted that each of these warning labels changed because of advocacy done by the “floxie” community. We screamed, and, slowly, the FDA listened.) Some people did successfully sue the drug companies that hurt them–they gained some compensation and justice.

Perhaps it’s cynical, but it certainly seems more logical than the BS explanation the Janssen spokesperson gave (noted above) that the reason that Janssen Pharmaceuticals took Levaquin off the market was because they didn’t want to be held liable for the blood sugar level changes and the mental health side-effects of Levaquin. They weren’t making much money off it anyhow (because of generics taking the bulk of the market share), this warning label update opened up a new load of liability, and they did a cost-benefit analysis that led them to take it off the market.

All’s well that ends well, and they took Levaquin off the market, and that’s a good thing, right? Well, it’s more complicated than that.

Because of a stupid and asinine rule put in place by the FDA and a lousy decision of the Supreme Court, victims of generic pharmaceuticals cannot sue generic pharmaceutical manufacturers. It all goes back to the “failure to warn” rules noted above. The FDA says that only brand-name drug manufacturers can change drug warning labels, and since generic drug manufacturers can’t change the warning labels, they cannot be held responsible for what’s on the warning labels. This results in victims of generic drugs being unable to hold anyone responsible for the harm done to them by the drugs. There have been a couple cases where brand-name drug companies were held responsible for the harm done by generic drugs, but the precedent wasn’t set very solidly, and most attorneys in most states still aren’t taking cases of people who have been hurt by generic pharmaceuticals. Still, I think that Janssen and J&J saw the writing on the wall–that they could potentially be held responsible for all the Levaquin and levofloxacin-induced mental health side effects, permanently disabling side effects, permanent peripheral neuropathy, tendon tears, and more. So, they hedged their bets. Their legal team, I’m betting, will now argue that they can’t be held responsible for the harm done by levofloxacin because they don’t even make Levaquin any more, and how can they be held responsible for a product that they don’t even produce? My reply is that they can, and should, be held responsible for the drug that THEY CREATED. Johnson & Johnson created and held the patent on Levaquin for a long time. They made billions of dollars off of it. They can, and should, be held responsible for the effects of their creation. The generic drug companies should also be held responsible for the harm that their drugs do, and the FDA should be held responsible for their warning labels (and failure to warn the public about these incredibly dangerous drugs).

We pushed the FDA to change their warning labels. They did, and we should be proud of that. The warning label changes scared Janssen and J&J enough that they stopped production of Levaquin, and we should be proud of that too.

We should also be diligent about the consequences of the removal of Levaquin from the market, and we should continue to work for change in the legal/justice system so that it leans more toward justice for victims, and less toward corporate protection. It is horridly difficult for victims of pharmaceuticals to gain justice or compensation through the legal system as it is currently set up. Janssen pharmaceuticals just made a move to make it even more difficult for victims of Levaquin and levofloxacin to gain justice.

Know what they’re doing. Stay on top of them. Celebrate our victories, then come back to the battlefield fighting. As long as millions of prescriptions of levofloxacin are distributed each year, and thousands of people are maimed by the drugs, our fight isn’t over.

Fluoroquinolone Antibiotics Associated with Carpal Tunnel Syndrome

It is well-known and well-documented that fluoroquinolones weaken and destroy musculoskeletal tissues–especially, but not limited to, tendons. 

Additionally, it is known that fluoroquinolones cause neurological problems, and can lead to painful and debilitating peripheral neuropathy. (In 2013, fluoroquinolone warning labels were updated to note that Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin can cause permanent and disabling peripheral neuropathy.)

Given that fluoroquinolones disproportionately affect the tissues in joints, and that they also adversely affect nerves (causing painful neuropathy), it’s not surprising that fluoroquinolone antibiotic use is associated with Carpal Tunnel Syndrome (CTS)–a medical condition that includes “pain, numbness, and tingling, in the thumb, index finger, middle finger, and the thumb side of the ring fingers,” as well as weakness and muscle wasting.

Both CTS and fluoroquinolone-use are common in America, and researchers Jasmine Z. Cheng, Mohit Sodhi, Mahyar Etminan, and Bruce C. Carleton, examined how they are related in “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” published in the journal Clinical Infectious Diseases in August, 2017.

In “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” the researchers found that, “Any use of FQ within the year prior to CTS diagnosis was associated with a 34% and 36% increased risk of CTS in the primary and sensitivity analyses, respectively” and that:

“The results of our study are consistent with an increase in the risk of CTS with FQs. The risk was consistent among all risk periods with a slight increase among past users, which may be due to the longer period elapsed for CTS to manifest itself. FQ-related neurotoxicity can persist cumulatively in relation to exposure levels [8, 9]. The exact mechanism by which this occurs is unknown [9], but proposed models include direct nerve inflammation and ischemia from toxic metabolite and free radical formation [10], and FQ-induced tendonitis/tendinopathy causing mechanical compression upon the adjacent nerves (eg, median nerve) that share the carpal tunnel [11]. Reports of nerve biopsy studies on patients who have experienced FQ adverse events have revealed significantly reduced nerve fiber density consistent with small fiber neuropathy, which may be a potential mechanism of CTS [12]. Although neurotoxicity is the second most commonly reported adverse event, with several studies documenting FQ association with central and peripheral nerve damage [8, 9], this is the first large-scale study exploring the relationship between FQs and CTS.”

CTS is a malady that affects thousands of people and has societal costs in the millions of dollars. In “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” the researchers note that:

“CTS is a disease of significant societal burden with a prevalence of 5% and incidence of up to 2.3 per 1000 person-years [4, 5]. CTS causes loss of function and decreased quality of life for individual patients, and also comprises a large cumulative drain on healthcare and socioeconomic resources from loss of productivity and worker’s compensation claims [6]. One study of 4443 CTS claimants in Washington State estimated a cumulative socioeconomic cost of US$197–$382 million over 6 years for this cohort alone [6].”

Fluoroquinolones are increasing the risk of CTS in millions of people (20+ million prescriptions for fluoroquinolones are written each year). Are doctors or patients aware that they are increasing the patient’s chances of CTS–a painful, debilitating, and costly condition–when fluoroquinolone antibiotics are taken? I doubt it, but they should be.

Please spread the word about how dangerous fluoroquinolones are by sharing posts, news articles, and research articles that connect fluoroquinolones with other illnesses. It wouldn’t occur to most people that a commonly prescribed class of antibiotics could be connected with CTS, psychiatric illness, pain, pseudotumor cerebri, tendon damage and ruptures, or multi-symptom chronic illnesses. But fluoroquinolones ARE connected with those, and other, diseases and syndromes. Articles like “Fluoroquinolone Use and Risk of Carpal Tunnel Syndrome: A Pharmacoepidemiologic Study” help to provide evidence of the extensive damage that fluoroquinolones do, and I am grateful to the researchers who examined the connections. Please spread the word so that doctors and patients alike are informed. Thank you.

 

 

Floxie Hope Podcast Episode 24 – PJ

PJ shared his journey through fluoroquinolone toxicity on Episode 24 of The Floxie Hope Podcast. Check it out!

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

PJ was given IV levofloxacin/levaquin and flagyl in the hospital, and afterward he suffered from multiple severe side-effects including debilitating fatigue, peripheral neuropathy, body-wide numbness, pain, inflammation in all his joints, and more.

He has come a long way, and he is 80% recovered.

PJ is wonderfully insightful and inspirational. Please listen to, review, and share, this episode of The Floxie Hope Podcast. Thanks!!

 

 

 

 

Floxie Hope Podcast Episode 23 – Tara

Tara shared her journey through Levaquin-induced fluoroquinolone toxicity in Episode 23 of The Floxie Hope Podcast. Please check it out!

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

You can also read more about Tara’s journey in her story:

https://floxiehope.com/taras-story-healing-from-levaquin-effects/

Tara has noted several times that she was not as far along in her journey as she thought she was when she wrote her story. Please listen to the podcast for more information about Tara’s journey. It is not a repeat of her story above.

Also, here is a different podcast that she did with her doctor:

https://floxiehope.com/2016/03/12/true-health-made-simple-podcast-featuring-tara/

Tara gives a wealth of information about her journey, and how complete avoidance of fluoride, along with various homeopathic methods, supplements, and other things, have helped her through the last two years.

Also, here are some notes and resources from Tara to accompany the information she gives in the podcast:

“What I’m told by fluoride experts is that it matters how much fluoride was already accumulated in your system if you get fluoride poisoned or if you are already sensitive to it by genetics or be because of other chemicals or stressors. Also, whether or not a person becomes hypersensitive does not seem to correlate with how badly they are injured. Ex: People who are hurt much worse than me, still may not become hypersensitive. The spectrum of sensitivity may not have anything to do with the amount of injury from what I can tell through research or peoples’ stories.”

“Also, Im not sure if I was clear about the Fluoride Poisoning symptoms – a person does not usually “feel” anything after ingesting fluoride or coming in contact with fluoride – only a hypersensitive person like myself, which is rare -most people who are poisoned because of fluoride just develop symptoms/diseases/disorders due to the enzymes, tissues, and structures that are poisoned. Most people discover they are poisoned from fluoride by getting completely off of it and symptoms get better (damage has to be repaired over time, some damage is not repairable for all people – but there is always hope of better).”

“Coffee – I forgot to mention this most important topic! 🙂 I was not able to drink anything caffeinated – not even a sip – for 20 months – using the SCIO to heal neurotransmitters (Adenosine is neurotransmitter associated with caffeine receptor site – also used SCIO to heal neurotransmitters in general helped immensely, to heal nerves, healing mitochondria DNA, food allergies, and attempting to desensitize from fluoride).

I am more than happy to report I can now drink a small cup of Bulletproof coffee (free of mold), and put Brain Octane (distilled coconut oil  – helps mitochondria for brain energy), butter (also good for brain), and when my fluoride is low enough, I can handle also putting in the Collagelatin powder in the coffee (good way to replace collagen and gelatin) for me. This is all mixed in a food processor together to combine – according to his book, there is a scientific reason why stirring doesn’t have same effects so needs to be blended.  I really like the taste and that it’s mold free. The founder of Bulletproof used to have Chronic Fatigue Syndrome, mold allergies, I think also Lyme, etc – so his story is good to read for inspiration – it brought him to a lot of research on mitochondria and health and building this very successful company.
bulletproof.com
(This is also the coffee I use for coffee enemas – it does matter that the coffee is pesticide and toxin free as possible – helped with small intestinal bacteria overgrowth SIBO)”

Resources:

Homeopathy – company name White Dove – Vitamin C, Bone Support, Pitui Liquitrophic, Fem Liquitrophic (I get these from my chiropractor’s office)
Solutions 4 supplements (chiropractor’s office)
MitoQ – mitoq.com
Pelican brimac bone char filtration system to remove fluoride – https://www.pelicanwater.com/whole-house-fluoride-filters
Allerphase (allergy/asthma herbal supplement – https://www.tangoherbs.com/allerphase60.html (side note: My son, 10-years-old, was able to get off his allergy and asthma medications – he has been on them since age 3, with the addition of Allerphase and MSM (from mercola.com), as well as getting off dairy/gluten and switching to an organic diet)
Harmless Harvest Coconut Water from Whole Foods (all coconut water is not made equal – some are highly processed – good idea to do some research – this is the one I use)
Infrared sauna – http://www.sunlighten.com/
Hyperbaric Oxygen Chamber Treatment – http://www.oxygenunderpressure.com/ – This is the HBOT Institute I went to – it’s a stand alone chamber by the Kansas City, MO airport – people from all over the United States come here for treatment – sessions were $125-$175 per session, 40 sessions is what was recommended. Expensive but worth getting my brain back.
Books:
Diagnosis and Treatment of Chronic Fatigue Syndrome and Myalgic Encephalitis by Dr Sarah Myhill
Eat Dirt by Dr. Josh Axe –
The Thyroid Connection by Dr. Amy Myers
The Wahl’s Protocol by Dr. Terry Wahls
The Devil’s Poison: How Fluoride is Killing You by Dean Murphy, DDS
Letting Go by Dr. David Hawkins
The Fluoride Toxicity Research Collaborative – http://www.slweb.org/ftrcfluoroquinolone.html
The Truth About Water Fluoridation by Charles Eliot Perkins (1952)
SpectraCell test – for minerals/vitamins/antioxidants/etc – also get test for iron and copper
Dr. David Gulledge, chiropractor for homeopathy, SCIO
Supplements suggested by the Fluoride Toxicity Research Collaborative (FTRC) for fluoride/fluoroquinolone toxicity (they lab tested to find good/cheap brands):
Calcium – solutions 4 brand or FTRC said Standard Process (can get from a chiropractor or naturopath) – fluoride binds to calcium and leaves the body in large quantities
Vitamin C with flavanoids- detoxes fluoride – they said Trader Joes brand with the lemon flavanoids. I do better with homeopath Vitamin C.
B-vitamins – fluoride disrupts synthesis of B-vitamins – (FTRC said Trader Joes brand)
Magnesium – fluoride chelates this mineral as well (FTRC said Kal brand – found at whole foods is good). I use Epsom Salt. If I wasn’t as sensitive to fluoride, I would choose Ancient Minerals magnesium lotion – loved it.
This article was sent to me by my chiropractor- it’s is by Dr. Jack Kruse – about being floxed and what to do about it – good information on staying away from EMFs, fluoride, etc. (I am very sensitive to EMFs since being floxed/fluoride poisoned)
Blue-blocking glasses I use to watch TV, look at my phone or computer – needed since being fluoride poisoned
Thank you for listening!

 

Books by Floxies

There are a couple of new books available on Amazon about dealing with, and making it through, fluoroquinolone toxicity. Both of the following books are written by “floxed” women, and both generously share a message of hope, perseverance, and strength through the difficult and painful journey of fluoroquinolone toxicity.

Praying Through Pliés: Living With Lupus and Surviving An Antibiotic Called Levaquin

Praying Through Pliés: Living With Lupus and Surviving An Antibiotic Called Levaquin by Rhonda “Jean” Bolton is described as follows:

“A nurse’s true and inspiring journey of living with lupus and later surviving a devastating reaction to the fluoroquinolone antibiotic, Levaquin, by weaving her faith and her love for ballet into a powerful story of transformation. Beautifully and poignantly written, the author addresses her personal loss, grief, sadness, and anger, but the prevailing message is one of hope, love, and gratitude. Included are sections on exercise, sleep, stress management, and nutrition with simple and realistic suggestions for change. This book has the potential to bring healing, hope, and joy to those dealing with chronic illness, loss, or challenges of any kind, but it is also is for anyone who desires to make positive changes in his or her life. Also written for those who suffer from adverse reactions to fluoroquinolone antibiotics and who are unheard or even discounted, this story provides support and encouragement, while adding one more voice of credibility to their pain and disabilities.”

In an email correspondence, Jean also noted that, “Early readers have said it is a powerful and inspiring story of healing and transformation. I combine faith and my love for ballet to offer others what I have learned about lifestyle changes in the areas of stress management, nutrition, sleep, stress management, and exercise, the importance of positive thinking, and the power of gratitude. My hope is that this book will bring hope and healing to others.”

Thank you so much for writing about your journey through fluoroquinolone toxicity (on top of autoimmune diseases) and for sharing it with the “floxies” of the world, Jean!

The Magnificent Story Of A Lame Author

The second highlighted new book about a woman’s journey through fluoroquinolone toxicity is The Magnificent Story Of A Lame Author by Amy Moser.

The author, Amy Moser, is also the author of the viral blog post, “This Antibiotic will Ruin You.” “This Antibiotic will Ruin You” was viewed and read MILLIONS of times, and greatly increased awareness of the dangers of fluoroquinolone antibiotics.

Amy followed up”This Antibiotic will Ruin You” withThe Magnificent Story Of A Lame Author. The Amazon description of the book states:

“When I was growing up, I pictured myself as a nurse, an olympian, an astronaut…but never handicapped. I just didn’t see that coming. I was as happy and enthusiastic to greet this new challenge, as I would be a swarm of bees. It can be very hard to accept great trial with open arms.
I might be lame, but my story isn’t. Nearly seven years ago at the age of 28, my body suddenly disintegrated underneath me. My doctors had no idea why my previously healthy body was imploding. I was a spunky young wife and mother stunned by her new circumstances. Discovering the cause offered no cure. What now? Where do I go from here?
When I’m overwhelmed by this burden, and I’m too heavy to forge ahead, the hand of God lifts me and leads me on. My journey is incredibly hard, but immeasurably blessed by God. Impossible situations give God opportunity to shine and us an opportunity to trust. Miracles wouldn’t be miracles if they were possible. You know the phrase, “When life gives you lemons…make lemonade.” I’ll give you a new one. When life throws you dung, use it as fertilizer to grow your mustard seed of faith. It may move a mountain or grant you the strength to traverse over it.
This story is about building an unconditional faith in God even during the most grueling moments of my life. I’m finding beauty and hope along a rugged path I never would have chosen for myself.”

An Amazon review of the book, from Roland, stated:

“Amy Moser has endured more pain and suffering than anyone should ever have and all because of one medication for a mild infection. Her heart for God and her iron clad faith in His goodness and mercy have kept her going for her devoted husband and her children. I have never read a stronger testimony about the power of prayer and an unwavering faith. This is a very important book because of the warning about Cipro and the other drugs in its category and how catastrophic the side effects can be. But more importantly, seeing her faith as she describes dealing with the truly awful things happening to her formerly healthy body is a gift to us all. Read this book. Learn more about the side effects of these dangerous drugs. They are horrifying. Then say a prayer for Amy Moser and all the others suffering because of these drugs.”

Both books are generously and thoughtfully written. They describe journeys of hope and faith, and they are gifts to those who read them. I hope that they help you through your journey through fluoroquinolone toxicity as well!

 

Do Fluoroquinolones Cause Cerebrospinal Fluid Leaks?

It is well known that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others) damage connective tissues–including musculoskeletal connective tissues like tendons, cartilage, bone, and muscle, as well as other connective tissues such as ocular tissue (including the retina), eardrums, and cardiac/heart tissue. Multiple studies have found that fluoroquinolones are toxic and damaging to connective tissues. Given the wide differences in tissues that fluoroquinolones have been shown to deleteriously affect–from cartilage to cardiac/heart tissue–it is reasonable to assert that they damage all connective tissues throughout the body. (Read any of the articles in the citations listed below for information about how fluoroquinolones damage connective tissues.)

Given that fluoroquinolones damage connective tissues (probably all connective tissues), I have a new, developing, hypothesis for how fluoroquinolones lead to fluoroquinolone toxicity syndrome/fluoroquinolone associated disability (FQAD). Please keep in mind that this is one of many hypotheses, and it is just one among about a dozen possibilities (you can read about some of the other possibilities on the post What is Fluoroquinolone Toxicity, or through the free ebook Hacking Fluoroquinolones.)

Hypothesis:

Fluoroquinolones damage the dura (dura mater)–the layer of connective tissue that surrounds the brain and spinal cord and keeps spinal fluid around those vital organs. This leads to spinal fluid leakage, which leads to many symptoms of fluoroquinolone toxicity, including:

  • Headaches (Including chronic migraines)
  • Autonomic nervous system dysfunction including POTS (postural orthostatic tachycardia syndrome) symptoms
  • Nausea and/or vomiting
  • Ringing in the ears (tinnitus) and hearing changes
  • Neck pain and stiffness
  • Radicular pain
  • Memory and cognitive problems (and other “neurolgic weirdness”)
  • Fatigue
  • Tachycardia (Racing heart/heart palpitations)
  • Dizziness (especially upon standing)

This wonderful lecture by Dr. Ian Carroll describes how cerebrospinal fluid leaks can lead to symptoms of many illnesses, including “mysterious” diseases like POTS, ME/CFS, fibromyalgia, as well as heart palpitations and severe headaches.

I suggest that you watch the entire video, as well as Dr. Carroll’s other videos on youtube. Here are some notes/highlights from the video above:

  • Many symptoms of POTS are actually cerebrospinal fluid leaks
  • The spinal cord is surrounded by tissue called the dura, and the dura holds cerebrospinal fluid around the spinal cord and brain. It’s like a water-tight bag that holds in cerebrospinal fluid and maintains pressure.
  • What causes people to have cerebrospinal fluid leaks?
    • Messed up connective tissue
      • From connective tissue disorders like ehlers danlos syndrome
      • (From fluoroquinolones???)
    • Something calcified and boney sticking into the dura
      • Bulging discs
    • Iatrogenic damage
      • Lumbar punctures
      • Epidurals
      • Back surgery
    • Car accidents (and other types of jarring, high-speed accidents)
      • Whiplash
  • How do you know if you have messed up connective tissue?
  • Calcium spikes sticking into the dura are difficult to detect via MRI, but they are clearer with a ct myelogram.
  • “Neurologic weirdness” is a sign of cerebrospinal fluid leaks. If someone is more confused later in the day, that can be an example of neurologic weirdness that results from a leak.
  • Cerebrospinal fluid leaks are misunderstood and under-recognized.
    • Post-puncture cerebrospinal fluid leaks are recognized.
    • Longer term cerebrospinal fluid leaks are less recognized and they present differently.
  • Post Dural Puncture Headache (PDPH) vs. Spontaneous Leak
    • Post Dural Puncture Headache (PDPH)
      • Single leak, orthostatic headache, 90% response to single EBP, Natural history understood and mostly benign, rarely mysterious, young women most at risk, fixable.
    • Spontaneous Leak
      • 30-40% multisite leak, late day headache, exertional headache, non-orthostatic CDH, 30% response to single EBP, natural history poorly understood and marked by chronic disability, often mysterious, HDCT, fixable.
  • There are people out there who have cerebrospinal fluid leaks that aren’t being recognized. Many people with cerebrospinal fluid leaks are misdiagnosed. Cerebrospinal fluid leaks are fixable and it is a shame that they aren’t all being recognized.
    • Cerebrospinal fluid leaks are NOT RARE.
  • Symptoms of cerebrospinal fluid leaks:
    • Headache, nausea and/or vomiting, ringing in the ears and hearing changes, neck pain and stiffness, radicular pain, neurological weirdness, fatigue
  • The effects of cerebrospinal fluid leaks on the pituitary gland
    • The pituitary gland is enlarged (How does this affect hormones???)
    • The connection between the pituitary gland and the brain can be disturbed, and this can lead to hormonal disruptions. High prolactin is an indicator of this problem.
  • Cerebrospinal fluid leaks can cause sagging of other parts of the brain.
  • MRIs of people suffering from cerebrospinal fluid leaks often appear normal. They are subtle and most doctors aren’t trained to see them.
  • Treatment of cerebrospinal fluid leaks
    • Epidural blood patches (Dr. Carroll describes how they’re done)
  • Cerebrospinal fluid leaks are NOT RARE, they’re just misdiagnosed and under-recognized

Before I watched Dr. Carroll’s lecture, I knew that cerebrospinal fluid leaks were painful and debilitating, but I didn’t realize that they were connected to “mysterious” disease symptoms or autonomic nervous system damage.

Connecting cerebrospinal fluid leaks to fatigue, a racing heart, blood pressure and blood sugar irregularities, tinnitus, cognitive and memory problems, hormonal abnormalities, etc. establishes a plausible connection between the (well-established) connective tissue damage done by fluoroquinolones, and the array of chronic, mysterious, disease symptoms that people with fluoroquinolone toxicity suffer from. Perhaps fluoroquinolones cause an array of debilitating chronic, mysterious illness symptoms through damaging the dura and allowing cerebrospinal fluid to leak–which leads to multiple symptoms of fluoroquinolone toxicity (and other chronic illnesses). It certainly seems like a plausible hypothesis to me. It actually seems like an easier hypothesis to postulate and prove than many of the other hypotheses regarding fluoroquinolone toxicity that have been put forth. As I noted above, the damage that fluoroquinolones do to connective tissues is well-established and recognized, and if someone looked at the effects of fluoroquinolones on dura mater tissue specifically, this hypothesis would be easily testable.

Some additional evidence supporting the possible connection between fluoroquinolones and cerebrospinal fluid leaks comes from the large number of people in cerebrospinal fluid leak support groups that have taken fluoroquinolones in the past who assert that fluoroquinolones contributed to their cerebrospinal fluid leak. I know that asking people in facebook support groups doesn’t count as a scientific study, but (to the best of my knowledge) no scientific studies of the link between fluoroquinolone use and cerebrospinal fluid leaks has been done, and the testimonials of the people who have cerebrospinal fluid leaks are important–they point both researchers and fellow patients toward research that may provide answers.

I also find it to be interesting that cerebrospinal fluid leaks affect the pituitary gland, which affects hormone production and regulation. Many people with fluoroquinolone toxicity syndrome have hormonal problems–from tanked testosterone to thyroid abnormalities. Maybe fluoroquinolones cause damaged dura tissue, which causes cerebrospinal fluid leaks, which causes pituitary gland structural abnormalities, which causes hormonal dysregulation, which causes multi-symptom chronic illness symptoms.

Dr. Carroll’s hypotheses and observations are fascinating and exciting for those who are dealing with fluoroquinolone toxicity and other multi-symptom, chronic, mysterious illnesses. I hope that they are explored further. Dr. Carroll’s results with patients are incredibly promising, exciting, and hopeful for people who are suffering from multi-symptom, chronic, mysterious illnesses–including those suffering from fluoroquinolone toxicity. I hope that Dr. Carroll, or other clinicians or researchers, look into the connections between fluoroquinolones and chronic cerebrospinal fluid leaks. It’s possible that the connections could lead to a comprehensive theory of fluoroquinolone toxicity, and may also lead to breakthroughs in other chronic illnesses.

Citations:

Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population. Hall, Mederic M. et al. PM&R , Volume 3 , Issue 2 , 132 – 142

Etminan M, Forooghian F, Brophy JM, Bird ST, Maberley D. Oral Fluoroquinolones and the Risk of Retinal Detachment. JAMA. 2012;307(13):1414-1419. doi:10.1001/jama.2012.383

Lee C, Lee MG, Chen Y, Lee S, Chen Y, Chen S, Chang S. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. JAMA Intern Med. 2015;175(11):1839-1847. doi:10.1001/jamainternmed.2015.5389

Adel Alrwisan, Patrick J. Antonelli, Almut G. Winterstein; Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study. Clin Infect Dis 2017; 64 (8): 1052-1058. doi: 10.1093/cid/cix032

 

Consumer Reports Warns Patients About Fluoroquinolone Dangers

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Consumer Reports has published several articles about the dangers of fluoroquinolone antibiotics (including Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and a few others). Their help in getting the word out to their readers about the risks associated with fluoroquinolone antibiotics is greatly appreciated!

The picture above, from the August, 2016 print issue of Consumer Reports, states:

These potent antibiotics are often prescribed to treat bronchitis, sinus infections, and urinary tract infections. But drugs such as ciprofloxacin (Cipro), levofloxacin (Levaquin), and ofloxacin (Floxin) can cause irregular heartbeats, depression, nerve damage, ruptured tendons, seizures, and other serious side effects. The Food and Drug Administration issued an alert in May saying that fluoroquinolones should not be used to treat bronchitis, sinus infections, and UTIs, unless other options have not worked.

Avoid Problems. If your doctor suggests a fluoroquinolone, ask why. For sinus infections, you might need an antibiotic if your symptoms last more than a week or if you have a high fever, but the first option should be amoxicillin. For a UTI, fluoroquinolones are only necessary if the infection is resistant to other antibiotics or has spread to your kidneys. And they are necessary for chronic bronchitis only if you require hospitalization.

In Fluoroquinolones Are Too Risky for Common Infections: The FDA advises restricting use of popular antibiotics such as Cipro due to dangerous side effects, Consumer Reports notes that the FDA “is advising against prescribing fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, to treat three common illnesses —bronchitis, sinus infections, and urinary tract infections.” The article also quotes Rachel Brummert, the Executive Director of the Quinolone Vigilance Foundation, and notes that her injuries from Levaquin include tendon ruptures and progressive nerve damage. The article also gives a guide of when to say no to fluoroquinolones. It’s an excellent article–please share it far and wide.

In Make Sure Your Doctor Prescribes the Right Antibiotic: There are safer, better options than fluoroquinolones and other frequently prescribed broad-spectrum drugs, the severe effects of fluoroquinolones are noted:

“For example, fluoroquinolone antibiotics such as ciprofloxacin (Cipro and generic) and levofloxacin (Levaquin and generic)—which are frequently prescribed inappropriately for sinus infections in adults—can cause permanent and debilitating damage to muscles, tendons, and nerves.”

As the title of the article says, there are safer, better options than fluoroquinolones (in many situations).

In Surprising Remedy for Deadly Hospital Infections: New study suggests doctors cut back on antibiotics. Here’s what you need to know. it is noted that fluoroquinolone use can lead to c. diff infections:

“Research published in The Lancet, a British medical journal, shows that when doctors in U.K. hospitals cut back on prescribing Cipro, Levaquin, and other so-called fluoroquinolone antibiotics, the rate of deadly infections from the bacteria known as C. diff dropped a whopping 80 percent.”

Fluoroquinolones wipe out the good bacteria that keep c. diff bacteria suppressed. When those good bacteria are eliminated, c. diff infections can take over. C. diff infections can be deadly, and all healthcare professionals should take note of this (somewhat counterintuitive) study.

All of the articles linked to above also note that fluoroquinolone over-use is contributing to antibiotic resistance.

In Meds That Cause Blurred Vision, Hearing Loss, and More: Painkillers, antibiotics, and other common drugs can trigger surprising side effects Cipro is listed as a drug that can cause double vision.

In I Didn’t Know That Antibiotics Shouldn’t Always be Used to Treat Bronchitis, Mary H. describes how Levaquin (prescribed to treat bronchitis) led to Stevens-Johnson Syndrome, which can be deadly.

All of these Consumer Reports articles are greatly appreciated, and I encourage you to read them, comment on them (where possible), and share them with your loved ones.

Consumer Reports has been a trusted source of information, and a strong advocate for consumer protection, since its founding in 1936. The articles linked-to above are from a highly respected source that is trusted by millions of people. It is a credible publication.

For a trusted and credible publication like Consumer Reports to be publishing information about the severe and varied health maladies that are associated with flouroquinolones is a huge step in the right direction. Their acknowledgement of the FDA’s updated warnings on fluoroquinolones, as well as the testimony of patients who have been hurt by fluoroquinolones, is appreciated immensely.

Thank you, Consumer Reports! Please keep it up, and hopefully other trusted news and consumer advocacy publications will follow suit.

 

 

Floxie Hope Podcast Episode 19 – Ian

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I had the pleasure and honor of interviewing Ian for Episode 19 of The Floxie Hope Podcast.

Check it out!

http://www.floxiehopepodcast.com/episode-019-ian/

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

Ian was an Olympic athlete prior to getting “floxed” by Levaquin. He has experienced severe fluoroquinolone toxicity symptoms, including multiple tendon tears that put an end to his cross-country ski racing career. Athletes should NEVER take fluoroquinolones. Ian went from being in the 2002 Olympics, to barely being able to walk around the block. If it can happen to him, it can happen to anyone. Please warn all your loved athletes so that they never take these dangerous, disabling antibiotics.

Ian is incredibly wise and insightful. His advice about how to face fluoroquinolone toxicity emotionally, mentally, socially, and psychologically is incredibly valuable. Please take the time to listen to him, and consider sharing this podcast with friends, family, and other loved ones. Ian’s measured and thoughtful voice of wisdom will help them to understand fluoroquinolone toxicity.

One thing that has recently helped Ian is KT tape. He posted this:

ian2kt

I had to let my body cure itself for 8 years, but then this KT and cloth tape job along with compromising my technique is what is enabling me to ski. I use about $25 worth of tape per week! I do this tape job on both legs every time I go out. I am very grateful to be able to ski some again!

Thank you all for listening!

I apologize for the poor sound quality. My voice echoes at the beginning of the podcast. Feel free to skip what I say – it’s not near as important as what Ian says. 🙂

 

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The Gaslighting of Patients

Gaslighting: A form of manipulation that seeks to sow seeds of doubt in a targeted individual or members of a group, hoping to make targets question their own memory, perception, and sanity. Using persistent denial, misdirection, contradiction, and lying, it attempts to destabilize the target and delegitimize the target’s belief.

Gaslighting occurs far too often to patients who experience adverse reactions to pharmaceuticals. Often, it is done by the people patients turn to when they are sick–our trusted advisors, our healers: our doctors.

I don’t think that most doctors mean to gaslight their patients, or that many of them are narcissists or abusers who intentionally manipulate people. I think that most doctors want to heal and help their patients. They use the information and tools that they have to move their patients toward health and well-being.

Yet, gaslighting is occurring.

When “floxed” patients approach their doctors with symptoms of fluoroquinolone toxicity (or FQAD-fluoroquinolone associated disability) they often face denial, derision, and hostility from the doctors who they are requesting help from. The doctors say that the symptoms that the patient is experiencing can’t be from the Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), or Floxin (ofloxacin), even though most of the symptoms of fluoroquinolone toxicity / FQAD are listed in the 40+ page warning labels. They say that the drugs should be out of the patient’s body, even though the black box warning label notes that fluoroquinolones “have been associated with disabling and potentially irreversible serious adverse reactions.” They say that they’ve never seen a patient who has had an adverse reaction to a fluoroquinolone–and that may be true, but are they looking? They say that delayed reactions can’t happen–but they’re documented. They deny that adverse reactions can happen, probably because they are in denial about the very real possibility that the drugs that they prescribe can cause serious, severe, and irreversible pain to their patients.

Then, they suggest that the patient see a psychiatrist and get on antidepressants.

Some people who experience adverse reactions to fluoroquinolones benefit from seeing a psychiatrist and taking antidepressants (though others are hurt further by both–be careful), and those things aren’t inherently bad, but the implication in suggesting psychiatrists or antidepressants is that patients who are experiencing adverse reactions to fluoroquinolones are crazy. We’re not crazy. Though some fluoroquinolone toxicity / FQAD symptoms are psychiatric, none of the symptoms, not even the psychiatric ones, are choices, decisions, or even the result of being crazy. All the symptoms of fluoroquiolone toxicity / FQAD stem from fluoroquinolone use and the damage done by these drugs.

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When a person, especially a doctor, suggests that all the symptoms of fluoroquinolone toxicity / FQAD are in a patient’s head, they are gaslighting the patient and making him or her feel crazy.

It’s dismissive, it’s obnoxious, sometimes it’s abusive, and it’s always wrong.

It happens all the time though, and I wish that it would stop.

Adverse reactions to fluoroquinolones (and other pharmaceuticals) are real, and they happen more often than they should. Denying that adverse reactions occur, then blaming the victim and telling him/her that he/she is insane, is not only useless, it is destructive. It hurts the patient/doctor relationship, and, more importantly, it hurts the patient. As I said above, I don’t think that many doctors intentionally seek to manipulate or hurt their patients. It’s happening though, and it needs to stop.

In the stories of patient pain and suffering from fluoroquinolones described on Fluoroquinolone Stories and The Fluoroquinolone Wall of Pain, doctor denial and gaslighting are described.

Sherry describes the gaslighting and denial that she experienced after taking Floxin and Flagyl:

“I went from doctor to doctor trying to convince them that these drugs did this to my body. They looked at me as if I had ten heads. They couldn’t believe that these medications could stay in one’s body for that long. I was crazy. I would bring them papers to show them proof and one doctor said to me that the medical community would use these papers for toilet paper!”

Cheryl notes the following experience after taking Ciprofloxacin XL:

“I went back to the pharmacist and told him the reaction I had. He said it can happen and it certainly sounded like I had an adverse reaction but he did not report it. I went back to the doctor how prescribed the drug to me and he did not believe me that I had reacted in that manner. Again, no reporting back to any authorities that I had an adverse reaction. I tried to show him the evidence of how many people have been damaged by this group of drugs and how dangerous they are and I was blown off. He told me he prescribes this drug all the time and has never had anyone react. I beg to differ because I bet people do have negative reactions but because they happen after the drug has been used, the connection between the aching muscles, nausea, anxiety, stiffness etc are not connected to the drug they took a month or more ago.”

There are many others.

Floxies are not alone in getting gaslighted by doctors. In the post “The Unintentional Gaslighting of Women and a Goodbye” Kerry Gretchen describes how her stroke that resulted from hormonal birth control wasn’t taken seriously by the doctors who treated her. Support groups for people who have had adverse reactions to a variety of pharmaceuticals and medical devices are full of patients who are frustrated and hurt when their doctor denies both their pain, and the cause of it.

The pain caused by pharmaceutical injuries is real, and patient pain should never be dismissed or denied. When denial of pain occurs, and patients are told that their symptoms are all in their head, it hurts the patient psychologically, and destroys the trust and bond between the patient and his or her doctor.

Doctors can stop this cycle through listening to their patients, not dismissing or disregarding adverse drug reactions as “rare” or “all in your head,” and being conscious of gaslighting as a phenomenon. Good, thoughtful, kind doctors don’t want to hurt or manipulate their patients, but, in order to maintain their worldview about the safety and efficacy of the drugs they prescribe, they often deny and deflect. Hopefully, with awareness of both gaslighting as a phenomenon, and how adverse drug reaction symptoms appear, the cycle will be halted.

 

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New Fluoroquinolones in the Pipeline

The most commonly prescribed fluoroquinolones are Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin. Almost every “floxie” that has been poisoned by fluoroquinolones in the last 15 years has taken Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin. However, there are many other quinolones and fluoroquinolones that have been developed. Here is a list:

First-generation:

Second-generation:

  • ciprofloxacin (Cipro) -Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • enoxacin (Enroxil, Penetrex) – withdrawn from the market
  • fleroxacin (Megalone, Roquinol) – withdrawn from the market
  • lomefloxacin (Maxaquin)  – withdrawn from the market
  • nadifloxacin (Acuatim, Nadoxin, Nadixa)  – withdrawn from the market
  • norfloxacin (Lexinor, Noroxin, Quinabic, Janacin)  – withdrawn from the market
  • ofloxacin (Floxin, Oxaldin, Tarivid) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • pefloxacin (Peflacine) – withdrawn from the market
  • rufloxacin (Uroflox) – withdrawn from the market

Third-generation:

  • balofloxacin (Baloxin) – withdrawn from the market
  • grepafloxacin (Raxar) – withdrawn from the market
  • levofloxacin (Leflox, Cravit, Levaquin, Tavanic) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • pazufloxacin (Pasil, Pazucross) – withdrawn from the market
  • sparfloxacin (Zagam) – withdrawn from the market
  • temafloxacin (Omniflox) – withdrawn from the market
  • tosufloxacin (Ozex, Tosacin) – withdrawn from the market

Fourth-generation:

  • clinafloxacin – Not withdrawn from market, but not commonly available
  • gatifloxacin (Zigat, Tequin) – Tequin removed from the U.S. market, but other forms remain available.
  • gemifloxacin (Factive) – Currently available. More commonly prescribed outside of the U.S.
  • moxifloxacin (Acflox Woodward, Avelox,Vigamox) – Still on the market. Millions of prescriptions dispensed annually worldwide. 
  • sitafloxacin (Gracevit) – withdrawn from the market
  • trovafloxacin (Trovan) – withdrawn from the market
  • prulifloxacin (Quisnon) – withdrawn from the market

Despite the fact that 22 of the 29 quinolones listed above have been removed from the market, and the fact that there is an updated black box warning label (the most serious warning possible on a pharmaceutical), that notes that the fluoroquinolones remaining on the market can cause permanent disability, several pharmaceutical companies are busily developing new fluoroquinolones.

Some of the fluoroquinolones in development include:

  • Delafloxacin (Baxdela) – Delafloxacin/Baxdela is being developed by Melinta Therapeutics, and is currently undergoing Phase III trials. It is supposed to be more effective at treating MRSA and other bacterial infections that are currently resistant to other fluoroquinolones. Melinta says that delafloxacin/Baxdela has a “favorable safety profile,” but, frankly, I don’t believe them. Bayer says that Cipro has an excellent safety profile, but thousands of people have been injured, disabled, and killed by it. Delafloxacin/Baxdela will be effective against gram-positive, gram-negative, atypical and anaerobic bacteria–meaning that it will be a broad-spectrum antibiotic that will kill all microorganisms in its path. I understand that MRSA is a serious, and potentially deadly infection, and that it may be appropriate to use an extra-powerful fluoroquinolone in cases of life-or-death. However, as an extra-strong fluoroquinolone, with an increased scope of bacteria that it kills, it will be a dangerous, and deadly for some, drug. I hope that delafloxacin/Baxdela will be reserved for treating life-threatening MRSA infections, and that it will not be prescribed for treatment of simpler or less dangerous infections.
  • JNJ-2Q – JNJ-2Q is being developed by Furiex Pharmaceuticals, who have licensed JNJ-Q2 from Janssen Pharmaceuticals, a unit of Johnson & Johnson. Like delafloxacin/Baxdela, JNJ-2Q is being developed for the treatment of MRSA, and it is also a particularly strong and potent fluoroquinolone. Again, I hope that it is only used for deadly MRSA infections.
  • Nemonoxacin (Taigexyn) – Nemonoxacin/Taigexyn, developed by TaiGen Biotechnology Company, is currently undergoing phase III trials in the U.S. However, it has already reached the market in Taiwan, Russia, Commonwealth Independent States, Turkey, mainland China, and Latin America. It is also more effective against MRSA than the fluoroquinolones that are currently on the market, and it is more potent than ciprofloxacin, levofloxacin, and moxifloxacin. Not-so-fun-fact – Nemonoxacin has been fast-tracked for approval by the FDA.
  • Zabofloxacin – Zabofloxacin was discovered by Dong Wha Pharmaceuticals and licensed to Pacific Beach BioSciences for development. It is currently undergoing clinical trials. “The spectrum of activity of zabofloxacin includes bacterial strains that are responsible for most community-acquired respiratory infections. Phase III clinical studies are currently ongoing at Dong-Wha for the treatment of patients with acute bacterial exacerbation of chronic obstructive pulmonary disease.” (source)

Be aware that these new fluoroquinolones are in the pipeline. Know their names so that you can avoid them.

I’m not sure how anyone else’s medical record works, but when I asked my doctor to put that I am allergic to fluoroquinolones on my medical record, her computer system wouldn’t allow her to do so. Instead, I had to list all of the fluoroquinolones that I wanted to avoid individually. I suggest that you tell your doctors not only that you can’t have fluoroquinolones, but that you can’t have Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin specifically. And, when they reach the market, I suggest that you add Baxdela/delafloxacin, JNN-2Q, Taigexyn/nemonoxacin, and zabofloxacin to your list of drugs that you cannot tolerate.

I find the dissonance between the people who review drug safety, and the people that approve new drugs, both of whom are within the FDA, to be a bit mind-boggling. How could the Antimicrobial Drugs Advisory Committee decide that the current warnings on fluoroquinolones are inadequate and that they shouldn’t be prescribed for sinus infections, colitis or UTIs, or chronic bronchitis because they are too dangerous, while another part of the FDA fast-tracks the approval of Taigexyn/nemonoxacin, an even more powerful fluoroquinolone antibiotic? Do they not speak to each other? I can’t fathom that there is not at least some overlap between the Antimicrobial Drugs Advisory Committee and the people who approve new antimicrobial drugs. Are there people at the FDA who are screaming about these new fluoroquinolones that are about to enter the market, and noting that they are horribly unsafe? Or, did the Antimicrobial Drugs Advisory Committee just update the warning labels on existing fluoroquinolones to shut up patient advocates (you and me)? Is there massive cognitive dissonance at the FDA? Because it certainly appears that there is. The people at the FDA, and the Antimicrobial Drugs Advisory Committee specifically, pretend to acknowledge the dangers of fluoroquinolones, and pretend to do something about those dangers, while still thinking that it’s appropriate to approve new, stronger fluoroquinolones for public use. It’s mind-boggling.

There is constant repetition of some mantra along the lines of “fluoroquinolones have an excellent record of safety and efficacy” among drug-makers, drug-regulators, and drug prescribers – despite a massive amount of evidence to the contrary. The list of quinolones/fluoroquinolones above clearly shows that 22 of the 29 drugs have been removed from the market–many because of serious safety concerns. Yet, new, more powerful, fluoroquinolones are entering the market, in part because, for some odd reason, Cipro and Levaquin are seen as “safe.” They’re not safe though. They cause permanent disability and death. The upcoming fluoroquinolones will be worse.

I hope that the new fluoroquinolones that are coming to market are only used to treat life-threatening MRSA infections, but I have no faith that that will be the case. These new fluoroquinolones will be marketed as being bigger/better/faster/more powerful than safer alternatives, doctors will prescribe them, and patients will suffer because of them. Hopefully I’m being too pessimistic, and some prudence will be shown in the prescribing of these dangerous drugs–I doubt that though.

Just be aware of the dangers of fluoroquinolones–both old and new, and protect yourself and your loved ones. Share information about the dangers of fluoroquinolones with your friends and family, and let them know that fluoroquinolones should never be used unless there are no viable alternatives, and the infection is life-threatening. These new fluoroquinolones are more powerful, and more dangerous, than the fluoroquinolones that are currently on the market, and the ones that are on the market are pretty horrible. They should all be avoided like the plague.

 

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Floxie Hope Podcast Episode 17 – Scott

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Scott is featured on Episode 17 of The Floxie Hope Podcast. You can listen to his insightful podcast through this link –

You can also download the podcast onto your phone or other device through any podcatcher that connects to iTunes. Thanks for listening!

Please note that this podcast is over two hours long because of some technical difficulties on my (Lisa) part. We recorded the podcast twice, and both recordings are included. The first part of the podcast is actually the second interview. I included it first because the sound quality is better on it. The second half of the podcast is actually the first interview. If you can stand the horrible sound quality (SORRY!), feel free to listen to it first. It starts around the one hour seventeen minute mark. This cartoon reflects the tone of the first (second recorded) part of the podcasts:

preventative-med
The second part of the podcast (first recorded) goes over more of Scott’s journey. Here are some notes from his journey that are helpful. From Scott:
  • One thing I forgot to mention during BOTH podcasts (LOL!) is that when I was in a lot of pain, it turns out that daily meditation helped my mental agony over my situation. It didn’t necessarily make the pain go away (although a few times, it felt like the pain disappeared during the meditation), but it definitely helped me mentally & emotionally deal with my situation much better. I use an app called Headspace, which talks you through daily 10-minute meditations.
  • Myofascial Release was my first glimmer of hope that maybe I could beat this thing. My first myofascial release session with Jody Hendryx of Verde Valley Myofascial Release in Sedona, Arizona was the first time that my pain disappeared in my ankles. I tried about 15 different myofascial therapists before realizing that Jody was the most skilled one that I could find, so I would recommend to people that they shop around to different myofascial therapists if they’re not feeling results.
  • I definitely recommend acupuncture visits and chiropractor visits. For chiropractor visits, The Joint is a nationwide company that I’ve been using with great results.
  • Collagen seems to have helped with some of my snapping tendons, although I still have many tendons that are still snapping. This is the brand of collagen that I take, mixed in with whole-milk yogurt (never fat-free nor low-fat yogurt): Vital Proteins Collagen Peptides
  • I found The Flox Report PDF to be very helpful for me, with a bunch of great hidden tips. The Flox Report does make it clear that not everybody can heal themselves from fluoroquinolone toxicity, but there are charts & tables which help you figure out where you fall on the spectrum of toxicity.
  • A very high-fat diet positively impacted everything for me with my health. I felt dramatic health improvements after starting this way of eating. Specifically, my diet is “high fat, medium protein, low carb, no sugar”. Some excellent books on this topic:
Great high-fat foods: Grass-fed butter, coconut oil, coconut milk (unsweetened), coconut flakes, avocados, guacamole, high-fat cuts of meat, high-fat cheeses (particularly raw cheeses), heavy whipping cream (unsweetened), olive oil, frying in lard/beef tallow/duck fat/ghee, eggs with yolks, sour cream, cream cheese, whole milk yogurt, seeds of all sorts (chia, hemp, sunflower), cacao (nibs/butter/beans), grass-fed & high-fat beef, ribeye steaks, pastured chicken WITH SKIN (that’s where the fat is), fatty bacon, fatty sausage, olives of all types, macadamias & macadamia butter, almonds & almond butter, pecans & pecan butter, walnuts & walnut butter, cashews & cashew butter, baking with almond flour/coconut flour/hazelnut flour/flaxseed meal.
Supplements & powerful foods that have helped me:
For nervous system (brain fog +  peripheral neuropathy):
For energy (chronic fatigue) + mitochondria repair + DNA repair:
For tendons:
For sleep (insomnia) and general health restoration:
Other Resources:
Thanks for listening!
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Neither Fluoroquinolone Toxicity, nor Recovery, are Rare

Last weekend I went to a seminar that has absolutely nothing to do with fluoroquinolones, drug safety, or advocacy. In that seminar I sat next to a guy who was roughly my age (30-something), and I began to tell him about my experience of getting hurt (poisoned) by Cipro/ciprofloxacin. I was about ten seconds into my story when he said, “Me too – Levaquin.” Yup, he was a fellow floxie. We chatted for a while, and exchanged stories of fluoroquinolone toxicity, then got back to the seminar.

There are a few things about my exchange with him that I’d like to share. First, he has largely recovered. He got hurt by Levaquin about a decade ago. He had severe musculo-skeletal problems (but not a lot of the nervous system symptoms that many floxies experience), and experienced pain in all the joints in his body. He went from being young, athletic, and capable, to barely being able to move. His pain and loss of capacity was so bad that he went through periods of contemplating suicide. Thankfully, he made it through those dark and painful times. He didn’t give me many details about how he got through the last decade, but he did heal. All of his joints (with the exception of his knees) are now strong and pain-free. He is able to work, socialize, and has recently started to exercise again.

The main thing that helped him was time. Knowing that time had helped others through similar experiences also gave him hope that his body would recover if he gave it enough time. For him, the amount of time that it took for his body to recover was a decade. I know that ten years is a long time, and for some of you it may sound like an unbearably long time. For others though, I hope that it is helpful and hopeful that time healed this guy’s body, and that maybe, just possibly, if you give yourself enough time, your body will heal too. (Of course, I don’t know how much time will heal you, or even if time will heal you, but I see it as hopeful that time healed him – even if it was a long time.)

The second thing that struck me about my conversation with this guy is that if two people meet in a random seminar, and both of them have had a life-altering adverse reaction to the same class of drugs, maybe that’s an indication that these reactions aren’t as “rare” as Bayer, Janssen Pharmaceuticals (a division of Johnson & Johnson), the FDA, and all others in the pharma machine would like us to believe. A floxie friend noted the following in a brilliant essay she wrote as part of a legal analysis about the alleged “rareness” of fluoroquinolone reactions:

Another way the risks are minimized is by listing these reactions as temporary or rare. The latter may be true in a technical sense, but what does ‘rare’ actually mean? A quick search of fluoroquinolone victim online support groups reveals that membership for most of them numbers in the tens of thousands, and the FDA’s Adverse Event Reporting System database garnered 3,101 reports of severe adverse reactions to fluoroquinolones in the last quarter of 2013 (the latest data available) alone. These are unscientific and anecdotal statistics, of course, but given that this class of antibiotic was prescribed to approximately 26.9 million patients during 2011 in the United States alone, ‘uncommon’ translates to 2.69 million domestic victims and ‘rare’ translates to 269,000. In fact, many more probably exist but are given a catch-all diagnosis of an ambiguous auto-immune disorder like fibromyalgia or are labeled with some other malady like diabetes, heart disease, hypothyroidism, etc., that arose spontaneously. Also, as in my case, a patient may take one or more courses previously without suffering an entirely noticeable reaction. Additionally, there is an unwillingness of medical professionals to admit a connection between the drug and these reactions. This is perhaps because, at first blush, it seems to defy logic that symptoms could take months to fully develop. But further research into biochemical complexities such as neurotransmitter and mitochondrial dysfunction is likely to explain why the damage follows a cascade-like pathological effect. For these reasons, the individualized nature of the reactions, and of course the patient’s illness itself, many victims surely never make the connection.

Of course disabling adverse reactions don’t happen to everyone who takes fluoroquinolones, but I still believe, as the author of the quote above does, that adverse reactions to fluoroquinolones are far less “rare” than pharma proponents would like us to believe, and that they are connected to many of the “mysterious” diseases of modernity for many.

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My encounter with the guy in the seminar also made me think that there are a lot more recovered “floxies” out there than most of us realize. In a comment on her story, Ruth noted:

My neighbor got floxed two months after I did. She made a 100% recovery. We had similar issues, but I was slightly worse than her. Until she talked to me she had no idea what had happened to her.

The music director for the parochial school/church where I worked two years ago got floxed, made an almost 100% recovery. She had some issues with her knee, having had a complete rupture of a tendon there and she is not young. But everything else resolved.

One of the pharmacy techs where I got the Cipro is a Floxie. She was very kind to me when I came there after my reaction. She was not there the day I picked up my prescription or maybe she would have warned me. She is 100% recovered.

My mother also knows someone who made a 100% recovery after a very bad reaction to a quinolone.

I don’t think that fluoroquinolone adverse reactions are rare, and I don’t think that recovery is rare. I also know that not everyone who gets hurt by fluoroquinolones recovers, and that there are many, too many, people who are permanently injured by Cipro, Levaquin, Avelox, Floxin, and their generic equivalents. Permanent injury, and Fluoroquinolone Associated Disability (FQAD), are not near as “rare” as they should be. None of the damage done by flurooquinolones is as rare as it should be. Too many people are getting hurt by these dangerous drugs. Even if many of them recover, poisoning people with dangerous and consequential drugs, when there are safer alternatives available, is wrong, and I hope that it stops soon.

 

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Podcast Participants Wanted

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There are 15 episodes of The Floxie Hope Podcast available at http://www.floxiehopepodcast.com/ and https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010. Each interview on The Floxie Hope Podcast is valuable and informative, and I encourage each of you to listen to the stories of your fellow floxies by downloading the podcast.

So far, episodes of The Floxie Hope Podcast have been downloaded 14,500 times. Thank you to everyone who has listened to the podcast!

Unfortunately, I’ve gotten a bit lazy when it comes to recording and releasing new episodes of The Floxie Hope Podcast. I’d like to change my momentum, and start putting up new podcast episodes again. If you are interested in being interviewed for The Floxie Hope Podcast, please reach out to me. You can reach me through this Contact form (please note in your message that you are writing because you’re interested in being on the podcast):

Everyone who has a fluoroquinolone story to tell is welcome to be on the podcast. Though I think that listeners appreciate tips and advice, you don’t need to be recovered in order to share your story on the podcast. All are welcome.

In addition to stories from floxies, I’d also love to interview the loved ones of floxies. If a spouse, child, parent, or other loved one of a floxie wants to be on the podcast, I’d love to interview them too.

I’m available to do interviews most evenings and weekends. If you’re interested in sharing your story on The Floxie Hope Podcast, please let me know. Thanks, and I look forward to speaking to you!

 

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Fluoroquinolone Toxicity is a SYNDROME

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First, a caveat–I realize that allergic reactions can be serious, severe, and deadly. There is nothing minimal about anaphylaxis, and not all allergic reactions to pharmaceuticals are as simple as hives that go away as soon as one stops taking the drug. If someone has an acute allergic reaction to a pharmaceutical they deserve care and recognition of their reaction as serious.

With that said, I’m sick of pharmaceutical-induced SYNDROMES being ignored because they don’t fit into the standard allergy model. Drug toxicity SYNDROMES are just as serious, devastating, and severe as allergic reactions. In my case, fluoroquinolone toxicity SYNDROME was significantly more serious, devastating, and severe than my sulfa antibiotic allergy.

Fluoroquinolone toxicity SYNDROME looks and feels a lot like various autoimmune diseases (rheumatoid arthritis, lupus, M.S., etc.), mysterious diseases (fibromyalgia, ME/CFS, POTS), psychiatric illnesses (depression, bipolar disorder, anxiety, etc.), and recognized drug toxicity syndromes (like benzodiazepine withdrawal syndrome). These symptoms, and the connections between these serious diseases and fluoroquinolones, should be recognized.

Here’s a post I wrote for Hormones Matter about the various drugs that are causing SYNDROMES of multi-symptom, chronic illness. Please read and share it:

Allergic Reactions or Iatrogenic Illness?

Thanks!

 

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Hope Heals and Unites

Over the past 3.5 years, this site has morphed and changed, and it has accumulated a lot of valuable information. It started out as a place to tell stories of recovery from fluoroquinolone toxicity. Over time, it became a repository for hundreds of articles about fluoroquinolones, and I started to write posts that focused on research. Fluoroquinolone toxicity became a puzzle that I wanted to solve, and many of the posts on this site are about that detective-work. I went to Washington D.C. in order to advocate for change in how fluoroquinolones are prescribed, and I wrote about those experiences. With that, this site became an advocacy site, and changes to medical and pharmaceutical policies were put forth. This site has become a supportive community, and I am grateful beyond words for the hundreds of people who have contributed more than 15,000 comments to Floxie Hope. It has grown, it has morphed, it has become more substantial and more effective with each post, article, and comment. I’m proud of this little site.

Though all its forms and purposes add to its value, I think that the most important and useful thing about Floxie Hope is it’s core and original purpose–to be a place where people can share stories of healing, resilience, recovery, and, most importantly, HOPE.

Fluoroquinolone toxicity is different for each individual who experiences it. Some people have absolutely devastating reactions, while others get off more lightly. Everyone’s symptoms are different, everyone’s timeline is different, and what helps and hurts each person is different. Also, we all have different backgrounds, personalities, characters, and approaches to life and illness. No matter the severity of an individual’s illness, or personality, or approach to life (both optimists and pessimists, religious people and non-religious people, rich and poor, etc.), we all need, and benefit from, HOPE.

Hope is healing, and it is necessary for healing. It’s not the only factor in healing, and I don’t think that we should try to hope fluoroquinolone toxicity away without doing anything else, but it is a valuable component none the less.

I hope for recovery for all those who suffer from fluoroquinolone toxicity. I hope for change in how fluoroquinolones are prescribed. I hope for acknowledgement of the devastation that fluoroquinolones inflict on the lives of their victims. I hope for less suffering and more healing.

Can we all agree on that? Can we all agree that healing and recovery are valuable, and that they should be hoped for? Can we agree that too many people are getting hurt by fluoroquinolones, and that we should hope for change? I think that we can agree on those things. Hope unites.

There are differences in what changes people think should be made. Some people think that all fluoroquinolones should be taken off the market, others think that they should remain available but that their use should be restricted. Some people think that the pharmaceutical companies can and will discover a cure for fluoroquinolone toxicity (and all the other “rare” diseases and adverse drug reactions out there), while others see the pharmaceutical companies as the problem, not the solution. Some people think that the FDA should be abolished for not adequately protecting people from the harm that prescription drugs do, while others think that working with the FDA is the best way to enact meaningful change. Some people fight, some people forgive, some people do a combination of the two–they’re not mutually exclusive. Some people question all aspects of the pharmaceutical industry (including vaccines), others think that fluoroquinolones are a particular bad apple, but other drugs and vaccines are good and helpful. Some people warn against throwing the baby out with the bath-water, others want to burn the whole system down.

I have been many places on the continuum of opinions above. I can see the perspective of anyone who argues for any of those things. Though I try to err on the side of hope (and continuity–I’m not really a “burn the mother****** down” person, no matter how much I want change), I can even see the perspective of those who are angry, and who want to destroy the entire system that hurt them. Anger can even be seen as hopeful–hoping for change on a visceral, emotional level. The experience of getting floxed, and taking the time to really process my thoughts and emotions about all steps in the journey, has led me to be a more compassionate, open, understanding, and empathetic person. I see perspectives that I didn’t see before, and I understand and value them even when I don’t agree with them.

The floxie community is diverse, and we could focus on our differences. I don’t think we should though. I think we should focus on the things that unite us. Hope unites us. Healing and recovery unite us–no matter what form they take. We’re all trying to do our best to recover, and to make it through this crazy world we live in. We want our health and safety, and the health and safety of our loved ones, first and foremost. Acknowledgement and paradigm shifts are nice too. If we focus on our common goals and strengths, we can get further than we can if we focus on our differences. Hope unites and it heals. We all need hope.

May this site give you hope. May it bring people together. May it be a resource and a community. May you heal. May we all heal.

 

 

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Vision Problems from Fluoroquinolones

A few years ago, I was chatting with a work associate about fluoroquinolone toxicity, and she mentioned that a friend of hers had lost her vision after taking ciprofloxacin. Yes, you read that correctly–her friend LOST HER VISION as a result of getting floxed. I was shocked and appalled. Losing my energy was bad enough, I can’t even fathom going blind, even temporarily, from taking an antibiotic. My associate’s friend had to take more than a month off of work, and several months off from driving, in order for her eyes to heal and her vision to return to a level at which she could return to doing those things. Her vision did return, and I believe that this was her only side-effect, but still, losing one’s vision is a pretty serious and severe side-effect. I’d be pretty upset if I COULDN’T SEE as a result of taking an antibiotic.

I have heard from many other people who have suffered from vision problems, including blurred vision, floaters, dry eyes, “visual snow,” and a loss of comprehension of visual information, post-flox.

In a comment on this site, Joyce described her vision problems as follows:

“Could Levaquin caused my visionroblem that happened sudden? Yes, I can type but onlyk because I’ve done years and years of 12-18 hour days of typing so as long as I know where the keyboard is, I can type — can barely see the letters so errors elude me.

Sunday, October 9, 2016, myvision went from being okay to not there in the blink of an eye — literally. My husband and I were eating lunch in a restaurant, someone sat down at a table near us, I glanced over, when I glanced back at my husband, my vision was gone except for a narrow bright white area to the right and bottom of my vision field. Called optometrist, he initially diagnosed a pin stroke and told me to go to ER, so I did. CT at ER showed nothing but as precaution, was given TPA and flown to major hospital. Three CT scans there showed nothing. Ultrasound of heart showed it to be in good shape. Cholsterol loa, blood sugar low, BP kept dropping on its own so docs happy with all that. MRI showed “shadow” in right temporal lobe — docs didn’t know if it was bleeding or what, nor how long it had been ther enor if it would go away.

Upper left quadrant of visual field seems as if I’m looking through a dense brown fog. Rest of visual field is useable — can get around on my own, do housework, walk, etc., but can’t see to drive, read nor do my job which is thypesetting and graphic design. Dark area has decreased by about 70% since initial onset but isn’t improving past that.”

In “Painful Dry Eyes” on www.fluoroquinolonethyroid.com, JMR describes her post-flox dry eyes as follows:

“The severely dry eyes affected everything: my ability to read, to watch TV, to use the computer, to write, to look out on the world; to be athletic, to be outside in the wind or cold night air; to blink the 23,000 -30,000 times a day the average person blinks without feeling the dry, gritty pain with each one of those blinks; to sleep at night without waking up constantly in pain just from my dry eyes alone. There’s “dry eyes”, and then there’s “Bone-Dry eyes” – zero moisture what so ever – and I simply couldn’t live a life worth living with that.”

The warning label for Cipro/ciprofloxacin notes that, “blurred vision, disturbed vision (change in color perception, overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus, hearing loss, bad taste, chromatopsia” are special sense related adverse-effects that have been reported. The warning label text feels so flippant–as if decreased visual acuity and/or eye pain aren’t serious, life-altering, horrible side-effects for a drug to have. Did anyone’s doctor warn them that they may have long-term vision problems as a result of taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin? No? I didn’t think so.

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If you read the full “Painful Dry Eyes” post on www.fluoroquinolonethyroid.com you will note the connections that the author makes between thyroid hormone (and iodine) levels and the severity of her eye-related fluoroquinolone toxicity symptoms. If you read through more posts on www.fluoroquinolonethyroid.com you will see that there are many connections between fluoroquinolone toxicity symptoms and thyroid hormones. A summary of the connection can be seen in the post “Fluoroquinolone Antibiotics and Thyroid Problems: Is there a Connection?” on www.hormonesmatter.com.

It is clear from patient reports that fluoroquinolones badly affect hormonal stability and balance. The site, www.fluoroquinolonethyroid.com, goes over how thyroid hormones are adversely-affected by fluoroquinolones. Patient stories such as Andrew’s Story and Gary’s Story go over how fluoroquinolones deplete testosterone. Many women have reported that their fluoroquinolone toxicity symptoms are greatly affected by hormonal fluctuations that correspond with their menstrual cycles. Additionally, in the article “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the Athletic Population” several endocrine-system disorders are listed as risk factors for fluoroquinolone-related musculoskeletal problems.

Hormones also greatly affect vision and eye health. In “Blinded By Side Effects: Vision and Hormonal Birth Control,” Kerry Gretchen states:

“Hormones affect every system of the body so perhaps it should come as no surprise that they can greatly impact your vision. In fact, it is the fluctuation in hormones that is the primary reason for worsening eyesight with age. So of course, manipulating the body’s natural chemistry by using hormonal birth control can cause a variety of vision problems.”

Blinded By Side Effects: Vision and Hormonal Birth Control is an interesting and insightful post that I recommend you read for more information about the hormone-vision connections. Though it focuses on how hormonal birth control affects vision–not on connections between fluoroquinolones, hormones, and vision problems–the connections just between hormonal disturbances and vision problems are interesting and relevant to “floxies” of both sexes.

I believe that post-flox vision problems are related to hormone imbalances. Working with a good doctor to help get your hormones back in balance (or, at least to run some tests) seems like an appropriate course of action for any “floxies” who are suffering from severe, life-altering, vision/eye related side-effects. Hormones are notoriously difficult to balance though, and caution is warranted. “Balancing your hormones” may be easier said than done, but working on it, and getting information from a doctor who works with patients with hormonal problems, seems like a good path to start down.

Time may also help. My peripheral vision floaters went away less than a year after getting floxed, and my eye moisture returned a few years after that. (My eyes were never dry to the point that they were painful, but I didn’t wear contact lenses for a while post-flox. I can wear them again.) I can’t pinpoint anything specific that helped other than time and maybe acupuncture. My vision problems weren’t near as bad as those of my work associate’s friend, Joyce, or JMR though. If my symptoms had been that severe, I probably would have been willing to try pharmaceutical and/or supplemental hormonal adjustments.

As is the case with most fluoroquinolone toxicity symptoms, there is no cure for vision-related fluoroquinolone toxicity issues, and even getting recognition of the reality of the multifaceted adverse-effects of these drugs is difficult.

Fluoroquinolone toxicity symptoms are severe, fluoroquinolones adversely affect multiple bodily systems including vision, and the symptoms of fluoroquinolone toxicity are often not reversible through medical interventions. Therefore, fluoroquinolones should not be prescribed unless absolutely medically necessary. This isn’t that difficult a concept–it should be reality.

 

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Children are Being Hurt By Fluoroquinolone Antibiotics

It breaks my heart when I hear about children getting “floxed.” It’s bad enough that fluoroquinolones inflict pain, tendon tears and ruptures, dysglycemia, insomnia, psychiatric problems, autonomic nervous system disturbances, hormonal issues, and more, on adults–it’s horrifying when those things happen to children. Our children, our babies, our innocent and precious kids, are getting hurt by fluoroquinolones too. We try to protect our children–it’s our job to protect them. We trust that when we go to the pediatrician, he or she won’t poison our babies, but, tragically, sometimes pediatricians do, indeed, poison children with fluoroquinolones. Sometimes they prescribe Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Floxin/ofloxacin to children, and sometimes those children suffer devastating consequences from taking those drugs.

It is so incredibly wrong to give children drugs that can cause permanent pain and disability that I’m furious that it happens at all. I’m also furious that there aren’t any consequences for the various parties that allow fluoroquinolones to be prescribed to children. In case it needs to be said, hurting children, and chemically causing pain and disability for young boys and girls, is wrong.

It is well-documented that fluoroquinolones cause permanent lameness in juvenile animals and that they are contraindicated for the pediatric population. A review in U.S. Pharmacist notes that:

“Fluoroquinolones have demonstrated adverse effects on cartilage development in juvenile animals through the inflammation and destruction of weight-bearing joints.  These arthropathies were often irreversible, and their potential occurrence in children limited the use of fluoroquinolones in this population.  In one pediatric study, ciprofloxacin had a 3.3% (9.3% vs. 6.0%) absolute risk increase in musculoskeletal events within 6 weeks of treatment compared with control agents used to treat complicated UTIs or pyelonephritis. Adefurin and colleagues found a 57% increased relative risk of arthropathy in children given ciprofloxacin (21% overall) versus those in a non-fluoroquinolone comparator arm. In contrast to animal models, neither dose nor duration had an effect on the rate or severity of arthropathy.  A 2007 study by Noel and colleagues determined the incidence of musculoskeletal events (primarily arthralgias) to be greater in children treated with levofloxacin compared with nonfluoroquinolone-treated children at 2 months (2.1% vs. 0.9%; P = .04) and 12 months (3.4% vs. 1.8%; P = .03).  These results and the severity of the effects should be weighed heavily when initiation of fluoroquinolones is being contemplated in pediatric patients.”

To summarize, fluoroquinolones can cause irreversible musculoskeletal harm and in doing so, they can put an end to a child’s days of running, jumping, playing soccer, skiing, dancing, etc. Think about that for a second–a drug, an antibiotic no less, can cause permanent damage to the musculoskeletal system of a child. Fluoroquinolones also have serious CNS effects, and can cause psychiatric disturbances as well as loss of memory and concentration. Children, with their developing bodies and minds, should not be subjected to dangerous, disabling drugs that can set back their development and their lives.

Given the documented adverse effects of fluoroquinolones on children, and the black box warning that notes that they can cause disability, the following examples of children being hurt by fluoroquinolones are both infuriating and heartbreaking. Still, I think they should be shared, so as to warn other parents of the dangers of these drugs, and hopefully fewer children will get floxed in the future.

I have paraphrased the stories that I’ve heard, but all of these are true:

  1. A 16 year old boy has Cipro 17 times over the last 7 years. He has various health issues, including a problem with the bones in his feet. The pain in his feet is so bad that he has had to stop school and homeschool on the computer.
  2. A 9 year old took fluoroquinolone ear drops twice as a toddler and suffers with chronic foot and knee pain.
  3. A young woman was floxed 4 1/2 years ago at 16 years old. After about 2 years, she got better, eventually reaching about 90-95% better, only to have a relapse for no apparent reason about a year later (which is where we are now)! She has had MANY devastating side effects, and still cannot work. When she got her first job is when the relapse took place.
  4. A 15 year old girl passed away 6 days after her 10 day Levaquin script.
  5. An 8 year old girl had to quit all sports swimming and gymnastics. She is now going to school but no P.E., and no Dr. Wants to take responsibility for how to help with her pain. It’s been only 2 weeks since taking 3 days worth and then being hospitalized because of the effects.
  6. A 10 year old girl who cannot stand or walk, and no doctors believe her. 
  7. A 16 year old girl took 2 pills of 500 mg of cipro and now has nerve twitching, leg pain, anxiety, and a whole bunch of other symptoms. 

These are kids! They are children and adolescents who are being hurt by fluoroquinolones. They are suffering and there is nothing that doctors can do to relieve their pain. It’s beyond heartbreaking–it’s infuriating–and it needs to stop. The FDA needs to put enforceable restrictions on pediatric fluoroquinolone use. The doctors who prescribe fluoroquinolones to children need to be held accountable when they hurt children with fluoroquinolones (either through Medical Board punishment, or lawsuits). The pharmaceutical companies that make these dangerous drugs need to be punished and they need to compensate their victims. Researchers need to be looking into a cure for fluoroquinolone toxicity. All parties involved need to help these kids to recover, because there really isn’t anything okay about hurting a child.

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Filing a Complaint with your State Medical Board

Iatrogenic Damage

Everyone who is suffering from fluoroquinolone toxicity has been hurt by the medical system–obviously. A prescription drug, an antibiotic no less, caused a multi-symptom illness that includes damage to connective tissue (tendons, ligaments, cartilage, muscle, fascia, etc.) throughout the body, damage to the nervous systems (central, peripheral and autonomic), and more, for those who are “floxed.” There are thousands of people who suffer from a myriad of adverse-effects as a result of taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, or other fluoroquinolone antibiotics. Despite the devastation that fluoroquinolones bring to their victims, and the fact that most symptoms are documented in various studies and on the FDA-published warning label, most victims of fluoroquinolones are unable to gain any sort of justice, retribution, or compensation for the damage done to them.

Justice System Failure

“Why don’t you just sue?” is a question that is commonly asked. While a complete answer to this question is more than I can give in this post, the short 2-part answer is that: A) People who are hurt by generic drugs cannot sue the maker of the drugs that hurt them, and B) If a symptom is listed on a drug warning label, you cannot sue for the drug causing that symptom. Most symptoms of fluoroquinolone toxicity are listed on the 43-page drug warning label, so if, for example, you suffer from toxic psychosis after taking a fluoroquinolone, you cannot sue for that severe and life-altering effect because “you were warned.” Never mind that few victims, and almost equally few medical professionals ever read the drug warning labels, much less the studies behind them.

Because suing is near-impossible for most victims of fluoroquinolones, thousands of people are left without any sense of justice or compensation for their losses.

What are fluoroquinolone-victims supposed to do? How are they supposed to get any sense of justice, retribution, or even acknowledgment or change?

Justice through State Medical Boards?

A recent note from a floxie friend gave me hope that some acknowledgement, and maybe some change, could come through filing complaints against the doctors (and other medical professionals) who are prescribing fluoroquinolones. Here’s her story:

My friend was an active senior citizen who enjoyed dancing before she was floxed. She is a petite vegan and was entirely healthy before she took ciprofloxacin. My friend recently filed a complaint with her State Medical Board against the Physician Assistant who prescribed her ciprofloxacin to treat an unconfirmed urinary tract infection. Her complaint asserted that the P.A. misdiagnosed her with a urinary tract infection and improperly prescribed fluoroquinolone antibiotics “which resulted in long term complications” (i.e. she got floxed).

My friend was pleasantly surprised when she received a letter back from the State Medical Board stating that they found that the P.A. was guilty of a “simple departure” from the standard of care. The letter explained that a simple departure from the standard of care is a “departure from the standard of practice,” and that “there must be two or more negligent acts or omissions before there is a violation of the Medical Practice Act.”

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Basically, this P.A. now has one strike against him, and if there is another Medical Board complaint against him, he can be found to be in violation of the Medical Practices Act, and disciplinary action can be taken.

Though I don’t know how the P.A. reacted to the findings, it is reasonable to assume that he isn’t happy about having one strike (of two) against his record. I would also guess that he’s not going to prescribe fluoroquinolones for unconfirmed UTIs (it turned out that my friend didn’t even have bacteria in her urine), and maybe he will refrain from prescribing fluoroquinolones again unless they are completely medically necessary. This, in itself, is progress. Having fewer doctors, P.A.s, and other medical professionals prescribing fluoroquinolones is a step in the right direction.

With the letter from her State Medical Board, my friend is approaching lawyers to see if any will take her case against the P.A. who prescribed her ciprofloxacin.

Perhaps filing complaints with State Medical Boards, and suing, doctors who hurt people through prescribing fluoroquinolones is one way to get change to happen.

Changing the System

If there are consequences for prescribing fluoroquinolones, perhaps more doctors will be cautious and prudent with them. If doctors hear of their associates having Medical Board disciplinary action taken against them, perhaps they will take the well-documented side-effects of fluoroquinolones seriously.

Fluoroquinolones are serious drugs with severe consequences. They should be prescribed with care and prudence, and, when they’re not, those who prescribe them inappropriately should face consequences.

If you were prescribed a fluoroquinolone inappropriately (the FDA recently changed the warning labels to note that fluoroquinolones should not be prescribed to treat bronchitis, uncomplicated cystitis, or sinus infections, and there are also documented reasons that athletes, children, people taking steroids or NSAIDs, immunocompromised individuals, and those with a history of psychiatric illness, should not be prescribed fluoroquinolones), your doctor should be reprimanded for inappropriately prescribing dangerous drugs to you–especially if those drugs hurt you.

I encourage everyone who was inappropriately prescribed fluoroquinolones to look into filing a complaint with your State Medical Board against the person who prescribed fluoroquinolones to you. Each State Medical Board has different forms and procedures, but you should be able to access them through Googling, “____(your State) Medical Board.”

I also encourage those whose fluoroquinolone side-effects were disregarded or ignored by doctors to file complaints with their State Medical Boards. The wide-ranging side-effects of fluoroquinolones are well-documented (HERE are hundreds of articles about the dangers of fluoroquinolones), and denial of documented drug side-effects is not appropriate. Perhaps with some Medical Board complaints, more acknowledgement of fluoroquinolone effects will come as well. That would certainly be nice, as acknowledgment is healing.

My friend has been empowered by the Medical Board findings, and I hope that she eventually gets justice. Disabling people with strong and consequential drugs, especially when they don’t even have an infection to begin with, is wrong. All “floxies” have to pay the consequences of taking fluoroquinolones with every loss that they sustain. Perhaps some of that burden should be shared by the doctors who inappropriately prescribe fluoroquinolones.

 

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FQ Toxicity Featured in The Healing Pain Summit

 

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I had the honor of being interviewed by Dr. Joe Tatta, DPT, CNS, for the Healing Pain Summit. In our interview, we discussed how fluoroquinolones can cause chronic pain and disability. Even before we spoke, Dr. Tatta was aware of fluoroquinolone toxicity and the pain and disability caused by fluoroquinolone antibiotics. He has treated several patients who have experienced the pain and trauma of fluoroquinolone toxicity. It was an honor to speak with a doctor as knowledgable, compassionate, and understanding as Dr. Tatta.

Please join me and Dr. Tatta, as well as an incredible panel of other guests (including Dr. Terry Wahls, Dr. Robyn Benson, Jessica Drummond, MSPT, CCN, Dr. Beth Darnall, Dr. Tyna Moore, DC, ND, Mira Dessey, Niki Gratrix, Dr. Jay Davidson, DC, Damian Dube, Dr. Reef Karim, Dr. Keesha Ewers, David Butler, PT, EdD, Marcelle Pick, OB/GYN NP, Karen Litzy, PT, DPT, Dr. Kim D’Eramo, Dr. Ann Shippy, MD, Dr. Mitchell Yass, By Debora Wayne, Dr. Ritamarie Loscalzo, MS, DC, CCN, DACBN, and Connie Zack – what a lineup!), for the Healing Pain Summit.

The Healing Pain Summit starts on Monday September 12th and goes through September 17th, 2016. You can register for the Summit for FREE through THIS LINK. After September 17th you can still access the interviews, but there is a charge for them.

I hope that The Healing Pain Summit helps those of you who are dealing with fluoroquinolone-induced pain!

I also hope that my participation in this wonderful event helps people to recognize that fluoroquinolones can cause chronic, and often debilitating, pain. I hope that my speaking out on the Healing Pain Summit helps people to “connect the dots.” There are a lot of people out there with fibromyalgia, chronic fatigue, joint pain, arthritis, rheumatoid arthritis, peripheral neuropathy, POTS, anxiety, and more, who have taken Cipro/ciprofloxacin, Levaquin/levofloxacin, or Avelox/moxifloxacin in the past, and those fluoroquinolones may have contributed to their painful conditions.

Please help me to spread the word about the pain caused by fluoroquinolones by sharing this post, with your doctors, friends, and loved ones. Thank you!!

Each guest on the Healing Pain Summit is offering a free gift to those who sign up. You can see the list of the free gifts HERE. The free gifts are incredibly useful and valuable, and I also hope that they help each of you!

A bit more about the Healing Pain Summit:

Through this expert event, Dr. Joe is completely rewriting the dialogue around pain, injury, healing and the growing epidemic of addiction to pain medications.

At no cost to you, Dr. Joe has gathered the top leaders in science and medicine to pull back the curtain and bring their top-notch, cutting-edge information on injury, illness, chronic pain, and pain management to you.  These are life-changing protocols and ideas that are just coming to light.

When you discover exactly how your body works and how to heal yourself naturally, you get your body working FOR you and not AGAINST you.

Thank you so much for joining me for the Healing Pain Summit! Also, a huge THANK YOU to Dr. Joe Tatta for including me and for the help in getting the word out about fluoroquinolone toxicity.

 

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Publicizing Fluoroquinolone Warnings

I have such mixed feelings about the FDA’s response to the November, 2015 Antimicrobial Drugs Advisory Committee meeting regarding fluoroquinolone safety. On one hand, I feel like they really did hear those who testified, and they not only listened, they responded in a way that showed that they listened. The FDA did what the Antimicrobial Drugs Advisory Committee recommended they do: they updated fluoroquinolone warnings to note that, “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options.” They not only updated the warning labels, they updated the black-box warnings–the most severe warning a drug can have. I am truly grateful for the steps forward in acknowledging fluoroquinolone adverse-reactions, and I’m hopeful that the updated warning labels will lead physicians and patients to realize that fluoroquinolones are dangerous drugs with potentially devastating consequences.

I wonder though, what good is an updated warning label? In the post, Who Reads the Drug Warning Labels? I go over the problem of people not knowing what is on the warning labels. Are physicians going to read the updated warning labels? Are patients? Is anyone other than the “floxie” community going to realize that the warning labels have been changed?

I appreciate the action taken by the FDA–I really do–but are updated warning labels actually going to change anything? Will fewer people get injured and killed by fluoroquinolones? I certainly hope that a significant portion of doctors hear about the warning label changes, and stop prescribing fluoroquinolones, but, unfortunately, the FDA isn’t taking any major steps to make this happen.

The FDA has no plans to inform individual doctors about the recent warning label changes made to fluoroquinolone warning labels. Even though the black-box warnings, again–the most severe warning label a drug can receive, have been updated to note that fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions, the FDA is not going to tell doctors about the changes. No “dear doctor” letter will be issued by the FDA. They will not do a massive publicity campaign to let physicians or patients know that the warning labels have been updated. They know about the dangers of fluoroquinolones, and, in their own way, they acknowledge them, but they’re not proactively communicating what they know to patients or physicians.

Since the FDA isn’t going to issue a “dear doctor” letter, it will likely be helpful if we (the people in the fluoroquinolone toxicity community, and those who care about drug safety) give the information the FDA has released to our doctors, local hospitals, and media.

I encourage everyone reading this to please, please, please send this information (that is directly from the FDA) to your doctors, the media, your friends, your loved ones, and anyone else who you think may benefit from the information. People need to know how dangerous Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, and Factive/gemifloxacin are. In order for them to know how dangerous these drugs are, we need to tell them.

Please forward these FDA releases to those who need this information:

  1. 5/12/16 – Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections
  2. 7/26/16 – FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
  3. July, 2016 Drug Safety Labeling Changes

Since most people don’t actually click on links, I’m also going to copy and paste what the FDA notices said (feel free to share this post with anyone who needs the information too).

Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections:

AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient

ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

See the FDA Drug Safety Communication for a list of currently available FDA approved fluoroquinolones for systemic use.

BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.

Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects:

SAFETY ANNOUNCEMENT

The U.S. Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, we revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. We also added a new warning and updated other parts of the drug label, including the patient Medication Guide.

We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.

Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones).

Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient’s treatment course (see List of Currently Available FDA-approved Fluoroquinolones for Systemic Use).

Fluoroquinolones are antibiotic medicines that work by killing or stopping the growth of bacteria that can cause illness. They are FDA-approved to prevent or treat certain serious bacterial infections.

The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA’s 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports* of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone (see Data Summary). We evaluated only reports submitted to FDA, so there are likely additional cases of which we are unaware. The side effects occurred within hours to weeks after starting the fluoroquinolone, and at the time we received the reports, the side effects had continued for an average of 14 months to as long as 9 years after stopping the medicines. Several cases reported that some side effects stopped or improved after discontinuation of the medicine; others reported the side effects worsened or continued.

We previously communicated about these safety issues associated with fluoroquinolones in May 2016. Additional communications about related safety issues associated with fluoroquinolones occurred in August 2013 (peripheral neuropathy) and July 2008 (tendinitis and tendon rupture). The safety issues described in this Drug Safety Communication were also discussed at an FDA Advisory Committee meeting in November 2015.

In addition to updating information in the Boxed Warning, we are also including information about these safety issues in the Warnings and Precautions section of the label. The Indications and Usage section contains new limitation-of-use statements to reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI). The patient Medication Guide that is required to be given to the patient with each fluoroquinolone prescription describes the safety issues associated with these medicines. We are continuing to assess safety issues with fluoroquinolones as part of FDA’s usual ongoing review of drugs and will update the public if additional actions are needed.

We urge health care professionals and patients to report side effects involving fluoroquinolone antibacterials and other drugs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

ADDITIONAL INFORMATION FOR PATIENTS

  • Fluoroquinolone antibiotic medicines are associated with disabling and potentially permanent serious side effects that can occur together in the same patient and should not be used to treat certain uncomplicated infections. These uncomplicated infections include acute bacterial sinusitis (ABS), acute worsening of bacterial chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI).
  • These side effects can involve the tendons, muscles, joints, nerves, and central nervous system, and can occur within hours to weeks after starting a fluoroquinolone medicine.
  • FDA has updated the Boxed Warning in the labels, added new warnings, and has revised the patient Medication Guide of all fluoroquinolone antibiotics.
  • Contact your health care professional immediately if you experience any serious side effects while you are taking your fluoroquinolone medicine.
  • Before starting a new fluoroquinolone medicine, inform your health care professional if you have previously experienced any serious side effects with another antibiotic.
  • Serious side effects involving the tendons, muscles, joints and nerves include:
    • Swelling or inflammation of the tendons
    • Tendon rupture
    • Tingling or pricking sensation (“pins and needles”)
    • Numbness in arms or legs
    • Muscle pain
    • Joint pain
    • Joint swelling
  • Serious central nervous system side effects include:
    • Depression
    • Hallucinations
    • Suicidal thoughts
    • Confusion
    • Anxiety
  • Other side effects include:
    • Abnormally rapid or irregular heart beat
    • Ringing or buzzing in the ears
    • Vision problems
    • Skin rash
    • Sensitivity of skin to sunlight
    • Headache
    • Trouble falling asleep
    • Fatigue
  • Read the patient Medication Guide you receive with your fluoroquinolone antibiotic prescriptions, which explains the benefits and risks of the medicine.
  • Talk to your health care professional if you have questions or concerns about fluoroquinolone antibiotic medicines.
  • We communicated safety information associated with fluoroquinolones in May 2016, August 2013, andJuly 2008.
  • Report side effects from a fluoroquinolone or any drug to your health care professional and the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

ADDITIONAL INFORMATION FOR HEALTH CARE PROFESSIONALS

  • FDA has approved label changes that reserve the use of fluoroquinolone antibacterial medicines when treating acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) for patients who do not have alternative treatment options.

  • FDA has also updated the Boxed Warning and the Warnings and Precautions sections of the labels and revised the patient Medication Guide of the fluoroquinolone drug class to describe the serious risk of multiple disabling and potentially irreversible adverse reactions that can occur together.

  • These adverse reactions primarily include tendinitis and tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects.

  • The adverse reactions can occur within hours to weeks after starting treatment with a fluoroquinolone medicine.

  • Discontinue the fluoroquinolone medicine immediately at the first signs or symptoms of any serious adverse reaction.

  • Avoid fluoroquinolones in patients who have previously experienced serious adverse reactions associated with fluoroquinolones.

  • Serious Adverse reactions of the musculoskeletal system and peripheral nervous system include:

    • Tendinitis/Tendon rupture

    • Muscle pain

    • Muscle weakness

    • Joint pain

    • Joint swelling

    • Peripheral Neuropathy

    • Serious Central nervous system effects include:

      • Psychosis
      • Anxiety
      •  Insomnia
      • Depression
      • Hallucinations
      • Suicidal thoughts
      • Confusion
    • Other adverse reactions include:

      • Exacerbation of myasthenia gravis
      • Prolongation of the QT interval
      • Hypersensitivity reactions/anaphylaxis
      • Photosensitivity/phototoxicity
      • Blood glucose disturbances
      • Clostridium difficile-associated diarrhea
    • Encourage patients to read the Medication Guide that they receive with their fluoroquinolone prescriptions.

    • FDA convened a public advisory committee meeting in November 2015 to discuss the risks and benefits of fluoroquinolone antibacterial medicines for the treatment of ABS, ABECB, and uncomplicated UTI. We also communicated safety information associated with fluoroquinolones in May 2016, August 2013, and July 2008.

    • Report adverse reactions involving a fluoroquinolone or any drug to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of this page.

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Levaquin/levofloxacin Warning Label Changes (Please see July, 2016 Drug Safety Labeling Changes for the other fluoroquinolone label changes:

BOX WARNING (revised)

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including LEVAQUIN®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue LEVAQUIN immediately and avoid the use of fluoroquinolones, including LEVAQUIN, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including LEVAQUIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid LEVAQUIN in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions, reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

WARNINGS AND PRECAUTIONS

Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects (addition)
  • Fluoroquinolones, including LEVAQUIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting LEVAQUIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue LEVAQUIN immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including LEVAQUIN, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Tendinitis and Tendon Rupture replaces Tendinopathy
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting LEVAQUIN, or as long as several months after completion of fluoroquinolone therapy… Tendinitis and tendon rupture can occur bilaterally.
  • The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue LEVAQUIN immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including LEVAQUIN, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.
Peripheral Neuropathy (new sentences added)
  • Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory…
  • …minimize the development of an irreversible condition…Avoid fluoroquinolones, including LEVAQUIN, in patients who have previously experienced peripheral neuropathy.

ADVERSE REACTIONS

  • The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
    • Disabling and Potentially Irreversible Serious Adverse Reactions (addition)
    • Tendinitis and Tendon Rupture (replaces Tendon Effects)

PATIENT COUNSELING INFORMATION

Serious Adverse Reactions
  • Advise patients to stop taking LEVAQUIN if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with LEVAQUIN or other fluoroquinolone use:
  • Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of LEVAQUIN and may occur together in the same patient. Inform patients to stop taking LEVAQUIN immediately if they experience an adverse reaction and to call their healthcare provider. (addition)
  • Tendinitis and tendon rupture replaces Tendon Disorders

MEDICATION GUIDE

What is the most important information I should know about LEVAQUIN?

Tendon rupture or swelling of the tendon (tendinitis).

  • Stop taking LEVAQUIN immediately and get medical help right away…
  • Worsening of myasthenia gravis (a problem that causes muscle weakness). Tell your healthcare provider if you have a history of myasthenia gravis before you start taking LEVAQUIN. (addition)

What is LEVAQUIN?

  • LEVAQUIN should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • LEVAQUIN should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.

Before you take LEVAQUIN, tell your healthcare provider if you:

  • have a disease that causes muscle weakness (myasthenia gravis); LEVAQUIN should not be used in patients who have a known history of myasthenia gravis.
  • have nerve problems; LEVAQUIN should not be used in patients who have a history of a nerve problem called peripheral neuropathy

How should I take LEVAQUIN?

Do not skip any doses of LEVAQUIN, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless:

  • you have nerve problems. See “What is the most important information I should know about LEVAQUIN?”

  • you have central nervous system problems. See “What is the most important information I should know about LEVAQUIN?”

     

All help in spreading the word about these FDA warnings will be greatly appreciated!

 

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Updated Black-box Warnings for Fluoroquinolones

In July, 2016, the FDA made significant changes to the warning labels for all fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, Noroxin/norfloxacin, and Factive/gemifloxacin). These label changes include black-box warnings for fluoroquinolones that state:

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including CIPRO®, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:
    • Tendinitis and tendon rupture 
    • Peripheral neuropathy
    • Central nervous system effects
  • Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions. Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis.
  • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions, reserve CIPRO for use in patients who have no alternative treatment options for the following indications:
    • Acute exacerbation of chronic bronchitis
    • Acute uncomplicated cystitis
    • Acute sinusitis

You can view all of the updated fluoroquinolone labels HERE.

These updated black-box warning labels are HUGE steps in the right direction. The FDA is acknowledging, in a highlighted black-box section of the warning labels, that fluoroquinolone adverse-effects can be serious, irreversible, and disabling. They’re also acknowledging peripheral neuropathy and central nervous system effects, in addition to the adverse-effects on tendons, in the black-box warning. Additionally, the black-box warning states explicitly that fluoroquinolones should not be used for treatment of patients with chronic bronchitis, uncomplicated cystitis (I wish they would have said “urinary tract infections” instead of “cystitis” as they did in the hearings and preliminary documentation), and sinusitis, unless there are no alternative treatment options.

If this updated black-box warning had been in place when fluoroquinolones were first introduced to the market (in the 1980s and 1990s), many people would have been saved from being “floxed.” If these warnings had been in place when fluoroquinolones entered the market, or even when people started screaming about the significant damages and injuries caused by fluoroquinolones, perhaps more doctors would be aware of the dangers of these drugs, and they would be used more appropriately (only in life-or-death situations where there are no alternatives available). Currently, unfortunately, most people are not aware of the devastating effects of fluoroquinolones. Hopefully this updated black-box warning label will enlighten both patients and physicians about the serious and severe dangers of fluoroquinolones.

Prior to this update, the black-box warning for Cipro (and other fluoroquinolones) stated:

Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS).

Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis (see WARNINGS).

This 2008 black-box warning was hard fought for, as both Bayer and Ortho-McNeil-Janssen (a subsidiary of Johnson & Johnson) wanted to bury the risks of tendon ruptures in small-text embedded in the warning labels, rather than highlighting the increased risk in a black-box warning. It was only after Public Citizen sued the FDA that this black-box warning was added to fluoroquinolone warning labels.

Though the old black-box warning was a significant victory at the time, it left much to be desired. The statement that, “This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants,” suggests that those who are under 60 years of age, not taking corticosteroid drugs, and who have not had kidney, heart, or lung transplants, can safely take fluoroquinolones. Though it is also noted that the risk of tendon ruptures is increased for people of “all ages,” it is common to hear of people being told that they wouldn’t have problems with fluoroquinolones because only older people, or people with myasthenia gravis, are at risk for experiencing adverse-effects. This simply isn’t true, as there are thousands of people who have been hurt by fluoroquinolones who are under the age of 60, do not have myasthenia gravis, who are not on corticosteroid drugs, and who have not had an organ transplant.

The old black-box warning gave people (both patients and physicians alike) the impression that fluoroquinolones are only unsafe for certain, small sections of the population. The truth is, fluoroquinolones can cause devastating, severe, disabling adverse-reactions in people who are young and old, strong and weak, fit and out-of-shape, and, at this time, there is no way to determine who will have an adverse-reaction and who won’t. There are almost certainly factors that predispose some people toward having devastating adverse-reactions to fluoroquinolones while others seem to be able to take fluoroquinolones without problem, but we don’t know what those predispositions are. No one knows if people who have latent autoimmune or endocrine system disorders, or who have MTHFR genetic mutations, or who are G6PD deficient, or who have leaky gut, or who have been exposed to heavy metals, or any other potential risk factor, are more succeptible to fluoroquinolone adverse-reactions than anyone else. There is a dice-roll, a pull of the Russian roulette trigger, every time ANYONE takes a fluoroquinolone because NO ONE knows what the real risk factors are, or even how frequent/rare adverse-reactions are. I wish that it was explicitly said on the fluoroquinolone warning labels, preferably in the black-box warning, that risk-factors are currently unknown and that everyone who takes fluoroquinolones is potentially at risk for experiencing disabling adverse-effects.

I also wish that it was noted in the black-box warning that adverse reactions to fluoroquinolones can be delayed for weeks, months, or even years after administration of the drugs has ceased. And I wish that people were warned that ceasing administration of the drug may not stop the adverse-reaction, and that the symptoms of fluoroquinolone toxicity can continue long after the drug “should” be out of one’s system.

I also wish that the danger of co-administering fluoroquinolones and corticosteroid drugs had stayed in the black-box warning, and I wish that the contraindication of NSAIDs and fluoroquinolones was noted in the black-box warning.

I wish that “cystitis” was changed to “urinary tract infection,” or that they were both mentioned as ailments for which the use of fluoroquinolones is not appropriate unless there is no alternative. I also wish that prostatitis and travelers’ diarrhea were added to the list of ailments for which fluoroquinolones should not be used unless there is no alternative.

Perhaps the next iteration of the black-box warning on fluoroquinolones will note those things. I wish I, and my doctor, had been warned more thoroughly about the dangers of fluoroquinolones before she prescribed them to me, and before I took them. Hopefully the updated black-box warning label will help physicians and patients to realize how dangerous fluoroquinolones are, and will keep many people from getting “floxed.”

Though the updated black-box warnings still leave a bit to be desired, they are a HUGE step in the right direction. Acknowledgement from the FDA that fluoroquinolone adverse-effects can be irreversible and disabling, and that they should not be used to treat many common conditions unless there are no other treatment options available, is very big news, and it should be celebrated. We are making progress, and hopefully fewer people will be hurt by fluoroquinolones because of these black-box warning updates.

 

 

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Preventing Fluoroquinolone Toxicity

I was talking with my boyfriend about yesterday’s post, “Researching Cures for Fluoroquinolone Toxicity,” and he brought up a good point:

Yes, a cure would be nice, but fluoroquinolone toxicity is just so preventable – prevention seems like a better strategy. 

Yes, we (as a society) could pour tons of money, time, resources, etc. into finding a cure for fluoroquinolone toxicity, OR we could stop floxing people and prevent them from needing said cure in the first place.

As Benjamin Franklin wisely noted, “an ounce of prevention is worth a pound of cure.”

For those of us who have been hurt by Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin, a cure is very much needed and wanted. We know our poison, now where’s our antidote? It’s a reasonable and appropriate question for those who have been hurt, but I believe that prevention of damage will help more people than a cure.

Dear doctors, nurses, pharmacists, and everyone else in the medical system: STOP prescribing fluoroquinolones unless your patient is fighting a verified, life-threatening infection that is not responding to other drugs! 

People are suffering from disabling fluoroquinolone toxicity reactions after taking Cipro when there are other viable treatments and/or when antibiotics aren’t even needed.

People are regularly prescribed Cipro to treat travelers’ diarrhea and some of those people experience debilitating adverse reactions to it. Their reaction and their suffering are avoidable though, because travelers’ diarrhea is treatable with more benign methods – probiotics, hydration, and Pepto Bismol should do the trick. Most cases of fluoroquinolone toxicity due to taking Cipro, Levaquin, Avelox or Floxin for travelers’ diarrhea are completely PREVENTABLE!

Even the FDA has acknowledged that the risks of using fluoroquinolones outweigh the benefits when treating sinus infections, bronchitis, and uncomplicated UTIs:

“FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.” (Source – straight from the FDA.)

Everyone who is suffering from fluoroquinolone toxicity after taking Cipro, Levaquin, Avelox, or Floxin as treatment for a sinus infection, bronchitis, or an uncomplicated urinary tract infection was hurt even though more benign antibiotics (or time, assuming that one’s immune system is functioning properly) could have been used.

Many cases of prostatitis aren’t bacterial, yet many men are given long courses of fluoroquinolone antibiotics to “treat” their prostatitis. In case it needs to be said, fluoroquinolone antibiotics are no better than placebos at treating non-bacterial prostatitis. Too many urologists are prescribing dangerous drugs (fluoroquinolones) that are no better than placebos, and hurting many men in the process.

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Many people are prescribed Cipro, Levaquin, Avelox or Floxin to treat non-bacterial bladder pain. Interstitial Cystitis (IC) is a great imitator of bladder infections, and fluoroquinolones do NOTHING to treat IC pain–they may even make it worse.

All the pain and suffering that comes with fluoroquinolone toxicity, and there’s a lot of it, is SO PREVENTABLE for so many people! Remember: DO NO HARM! 

According to FDA figures, 26.9 MILLION prescriptions for fluoroquinolones were disbursed in 2011 alone (they haven’t updated their figures since 2011). Too many of those prescriptions were inappropriate. Many of them were for ailments that weren’t even bacterial infections.

“‘Antibiotic therapies are used for approximately 56 percent of inpatients in U.S. hospitals, but are found to be inappropriate in nearly half of these cases, and many of these failures are connected with inaccurate diagnoses,’ study author Dr. Greg Filice said in a news release from the Society for Healthcare Epidemiology of America.” (source)

Everyone in the medical system needs to recognize that adverse reactions to fluoroquinolones are disabling, often permanent, and that they look a lot like a multi-symptom, chronic illness. Unfortunately, at this time, there is no way to tell who will have an adverse reaction to a fluoroquinolone, so, as far as doctors should be concerned, EVERYONE is at risk. Fluoroquinolones are dangerous drugs, and their benefits do not outweigh their risks for many infections. They should ONLY be prescribed for treatment of verified, life-threatening infections that cannot be treated with more benign drugs.

If those basic rules were followed, there would be significantly fewer “floxies.”

Prevention is the answer to this problem.

A cure would be nice, but prevention is better.

The FDA acknowledges that fluoroquinolones have potentially permanent adverse effects, and that their risks outweigh their benefits for many patients/conditions. Now the FDA needs to put some policy changes behind this knowledge, and make sure that fluoroquinolones are not prescribed inappropriately.

Enacting policies that cut fluoroquinolone prescriptions by about 90% would be a good place to start.

Yes, there are cases when fluoroquinolones are the appropriate drugs to use – when a patient is facing death without the drugs. But a large portion of the prescriptions being written for Cipro, Levaquin, Avelox, and Floxin are completely inappropriate. A large portion of the pain, suffering, and destruction caused by fluoroquinolones is preventable.

The FDA is capable of enacting policies that prevent many cases of fluoroquinolone toxicity. They have the information, they have the power, they need to do what is right –

Stop unnecessary fluoroquinolone prescriptions! Prevent disabling fluoroquinolone toxicity!

There are safer drugs available in most cases.

 

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Dear Colleague Letters: Information about Fluoroquinolone Toxicity from Doctors to Doctors

Several doctors have written “Dear Doctor/Colleague” letters regarding the horrible, damaging effects of fluoroquinolones. I appreciate all of these doctors who are speaking out about the dangers of fluoroquinolones, and I encourage you to read, print, and share each of these letters:

Additionally, the following “Dear Colleague” letter from Lawrence W. Rodgers, Jr. MD was recently brought to my attention. Dr. Rodgers’ wife has suffered from the adverse-effects of fluoroquinolones, and he wrote this thoughtful letter to his colleagues about her experience and the experiences of some of his patients.

Dear Colleague:

I am writing this letter to describe my journey as a physician in understanding the potential devastating and life altering side effects of Fluoroquinolones on patients. I am a practicing ENT physician in Florida. My training included Medical School at the University of Florida where I was Alpha Omega Alpha and graduated 10th in my class. Residency training as an Ear, Nose, Throat and Head and Neck surgeon was completed at the University of Florida.

During my career as a physician in private practice I have prescribed oral Levaquin, Avelox and Cipro for over 20 years. Usually this was given for chronic sinusitis.

My wife was given oral Levaquin twice, Avelox once and then Factive over a four year period of time. Her first Levaquin precipitated peripheral neuropathy in August 2008. She had persistent and then worsening symptoms since that first injury seven years ago. In retrospect she suffered acute onset connective tissue symptomatology, severe neurocognitive injury, marked prolonged fatigue and peripheral neuropathy related to taking these antibiotics. The onset of these side effects varied from acute, within a few days of beginning the drug to later onset. To this day she suffers ongoing peripheral neuropathy, neurocognitive difficulty and persistent fatigue with joint and back pain, also visual change and thyroid dysfunction. Her life has been permanently altered. I consider myself a good physician but I was unable to recognize these injuries as arising from the Fluoroquinolones because I was not looking for these drugs as the culprit. The differential diagnosis was complicated. Now I realize these medications as the direct cause and effect.

As I realized the potential side effects of Fluoroquinolones I began looking for this in my patients. In my experience over the last two to three years three patients come to mind. One who experienced acute significant vertigo lasting almost three months from the use of oral Levaquin. A second patient with acute onset severe debilitating lower extremity pain from oral Levaquin caused him to be unable to work as a truck driver for two months. A third patient is a 23 year old girl given oral Levaquin by her primary care physician for sinusitis. She immediately experienced severe ankle and foot pain within a few days of taking oral Levaquin. This patient worked as a horse trainer and rode horses daily. She quickly became unable to do her job because of severe ankle pain as she tried to place her feet in the stirrups as she rode. The patient was referred to me because of persistent sinusitis. This was cleared with the use of other antibiotics. My young patient had persistent ongoing debilitating ankle and lower extremity pain and was unable to continue in the work she enjoyed. This was noted at her last visit with me to be persistent six months after discontinuing the Levaquin. More details concerning these patients are available if you would like to discuss them with me.

This is anecdotal but caused me to review other information and studies of the potential side effects of Fluoroquinolones. In my experience I conclude these are dangerous and potentially life altering medications and should only be used in life threatening situations. The most important adage I learned as a young medical student was “First do no harm”, a very valuable basic principle for any physician. It is my belief and experience that the over prescribing of these antibiotics violates this basic principle of medicine. I no longer prescribe Fluoroquinolones to my patients. I will be happy to discuss my experience at any time.

Sincerely,
Lawrence W. Rodgers, Jr. MD
Otolaryngology

I am grateful for all of the doctors who have taken the time to speak out to their colleagues about the dangers of fluoroquinolones! As more doctors realize the dangers of these drugs, more will follow in the footsteps of doctors like Dr. Rodgers who no longer prescribes fluoroquinolones to his patients.

 

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FDA Advises Restricting Fluoroquinolone Use

May 12 flox victory

On May 12, 2016 the FDA released the announcement, Fluoroquinolone Antibacterial Drugs: Drug Safety Communication – FDA Advises Restricting Use for Certain Uncomplicated Infections. It stated:

FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.

An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.

This is huge, wonderful news for the “floxie” community!

The middle paragraph of the FDA announcement is particularly gratifying. The FDA is acknowledging that fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin) are associated with “disabling and potentially permanent serious side effects that can occur together.” They are acknowledging that fluoroquinolones can lead to multi-symptom chronic illness, and that’s HUGE! Fluoroquinolones don’t only cause one or two of the side-effects listed on the warning label in isolation, they cause a syndrome of illness. For the FDA to acknowledge this is an enormous step in the right direction. (More on the FDA’s acknowledgement of Fluoroquinolone Associated Disability, FQAD, can be found in the post, “An Official Name: Fluoroquinolone-Associated Disability (FQAD).”)

This acknowledgment from the FDA grew out of thousands of people reporting their symptoms to the FDA, speaking out to the media, and testifying before the FDA.

The change in fluoroquinolone warning labels stemmed from the November 5, 2015 meeting of the FDA’s Antimicrobial Drugs Advisory Committee meeting to discuss, “the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.” Hundreds of victims of fluoroquinolones, as well as doctors, attorneys, journalists, and other supporters, attended the Antimicrobial Drugs Advisory Committee meeting, where 30+ people were able to tell their story of how fluoroquinolones had devastated them and their loved ones–causing multi-symptom, chronic illness that resulted in disability and even death for many. The transcript from the meeting can be found HERE. The committee listened, and ruled that the current warning labels on fluoroquinolones were not sufficient, and that fluoroquinolones are not appropriate for use in treating minor infections.

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Because the FDA has a history of not doing as their committees request, and because action can take years, those in the fluoroquinolone injured community weren’t sure whether or not the victorious ruling at the committee level would translate into changes to the actual warning labels. However, on May 12, 2016 the FDA made the announcement that the warning labels for fluoroquinolones would change to note that the risks of fluoroquinolones outweigh their benefits in the treatment of patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. The announcement, and the ensuing warning label changes, mark a moment of victory and vindication for victims of fluoroquinolones

Though many people don’t think that changing the warning labels is enough (and they have very good, legitimate reasons for thinking that warning label changes are inadequate), it is a step in the right direction. With warning label changes, perhaps doctors will acknowledge fluoroquinolone toxicity and restrict their use of fluoroquinolones. Additionally, warning label changes open doors for lawsuits, and lawsuits have the power to hurt the pharmaceutical companies and help victims of fluoroquinolones to gain justice. If the warning label changes include language like, “An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.” the door will be open for many floxies with many symptoms to sue Bayer and Johnson & Johnson, the makers of Cipro, Levaquin and Avelox. Lawsuits, if successful, may bring about change in the distribution of fluoroquinolones, and may also help victims of fluoroquinolones to gain justice and possibly even healing.

The FDA announcement has also led to media coverage, and with media coverage comes additional awareness. The word is spreading far and wide as to how dangerous these drugs are.

The FDA announcement is a massive step in the right direction, and May 12, 2016 is a very good, victorious, vindicating day for victims of fluoroquinolones. It is a day to celebrate!

Cheers, my friends!

 

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Comments From Doctors About Fluoroquinolone Toxicity

With every article about fluoroquinolone toxicity that is published (there are hundreds HERE), more and more people come forward and say, “that happened to me too,” or, “those drugs hurt my family member,” or some variation/elaboration of those sentiments. As awareness grows, more and more doctors are coming forward to say that fluoroquinolones are dangerous drugs whose risks are under-recognized. Growing awareness and recognition, especially from doctors, nurses, and other medical professionals, is important in the fight to reduce the number of lives ruined by these dangerous drugs.

It recently came to my attention that there were many good comments from doctors and other medical professionals on an article in Medscape Medical News, “FDA Panel Says Fluoroquinolones Need Stronger Warnings.” (If the link leads you to a sign-in form instead of the article, just google “FDA Panel Says Fluoroquinolones Need Stronger Warnings” to skip the sign-in-wall.) It should be noted that Medscape Medical News is aimed at medical professionals, and that one needs to work in medicine in order to comment on stories on the site. The comments are, for the most part, a conversation between doctors. It is heartening to see that most of the comments are supportive of the notion that stronger warnings are needed on fluoroquinolones, and that the real risks of Cipro/ciprofloxacin, Levaquin/levofloxacin, Floxin/ofloxacin and Avelox/moxifloxacin are under-recognized and under-appreciated. Several of the commenting doctors also noted that these drugs should only be used as a last-resort, after all other options had been exhausted.

In this post, I’m going to highlight some of the comments that were published on “FDA Panel Says Fluoroquinolones Need Stronger Warnings.” It’s good for “floxies” to hear from doctors who recognize the pain caused by fluoroquinolones, who are also fighting for more prudent and appropriate use of these dangerous drugs. It’s nice to hear from doctors who recognize that fluoroquinolones can cause a multi-symptom chronic illness, and that fluoroquinolone toxicity is not a simple “side-effect.” A huge “THANK YOU” to all the doctors who left supportive comments on the article! Conversations between doctors about the dangers of fluoroquinolones are going to do a lot to change how fluoroquinolones are thought of and prescribed.

Here are just a few of the comments (I ended up copying/pasting most of them, but there are still some gems left behind in the comments section of the article):

“At the age of 39, I suffered horribly from the use of Cipro. It changed my ability to practice Anesthesiology. I had to go to barely part time work when this occurred and could barely move. I had no preexisting health issues prior to the use of this fluoride containing poison in my opinion. I still have evidence of its destruction 6 years later. I have met several other individuals who have also suffered among them a classical pianist, two other physicians and several other highly educated individuals whose lives were changed monumentally especially for the first one to two years post “poisoning” as I call it.

The toxicity of this class of drugs is predominantly musculoskeletal and neurologic and I can truly sympathesize with patients who have been “blown off”as hypochondriacs by their PCP s or others when they present with severe musculoskeletal pain and neuro and neuropsych issues. There are other SE as well in various organ systems however as noted most seems centered in the MS and neuro psych realm. Many have expansive work ups (as did I) to rule out ominous diagnoses all to no avail but suffer greatly nonetheless in terms of years not weeks or months!

Fluoroquinones are cytotoxic to chondrocytes and the vasa vasorum is also thought to be greatly affected at the microscopic level and may lead to the neuropathy. Some feel this propensity in patients to suffer what is called (By victims of these drugs)”FQ syndrome”may point to a mitochondrial source.

Just because there is no blood test to measure the damage these poisons wreak on previously well patients or because the wide range of symptoms patients experience has yet to be acknowledged and named a formal syndrome, doesn’t mean the horrible side effects aren’t real or don’t exist. To do so, is folly. I was finally diagnosed at a well known academic center by a neurologist in conjunction with rheumatologist. Also of interest is the flood of multiple significant musculoskeletal and neurologic complaints suffered by a large proportion of government workers who were given Cipro after the Anthrax scare several years ago. However, again, many people were dismissed then.

One thing is certain is that significant side effects of these medications exists and failure to acknowledge patients who present with what seems to be a “positive review of systems” after FQ use should be taken seriously. Especially true when as a physician you know your patient was previously healthy prior to FQ use and not a patient who routinely presents with multiple mundane complaints.

I feel and have read many patients who experienced nearly identical symptoms to the ones I suffered. Most all blown off as head cases. If more physicians would entertain the possibility a FQ may be responsible for their patients suffering, maybe then they would

Report to the FDA and we would have a true idea as to the incidence of life changing and sometimes permanent havoc these drugs wreak on our patients. In my case, I’ve lived it and I welcome the added safety warnings on these drugs. People have abused these drugs which are extremely broad spectrum and powerful for conditions that don’t require a hammer to kill an ant. Hoping these warnings will ease the indiscriminate use of these very potentially damaging drugs.”

“This does not even mention the risk of acute toxic psychosis. I have witnessed it in a 17 year-old on levofloxacin for h. pylori. Dramatic, acute onset of psychosis after two doses with no prodromal history. There are more cases out there I understand. I have learned to reserve these drugs for cultured bacteria for which there is no other reasonable alternative. It is not a reasonable choice for prophylaxis or starting treatment pending culture results in my opinion.”

“I, myself, have had major issues with this class of drugs.  Took Avelox in July 2013 for an upper respiratory infection without issue.  Was given Avelox again in November of 2013 and within 10 minutes of my first pill, I was in anaphylactic shock.  I was transported to the ER and nearly died!  Over previous years, I was given Levaquin and Cipro for other URI s.  Guess my body had enough.  My joints are shot and I will never be the same again.”

“I agree with need for stronger language even a black box warning and better education of prescribers.”

“I am a nurse, and i never knew about this until i took Levoquin and Cipro. Now i am a disabled person. I lost my life. The side effects are not being reported. Check the study UCSD (University of California, San Diego) is doing. Thanks for reading our notes and joining in.”

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“I am a BSN, RNC-NIC nurse.  I had been given Levoquin and Cipro both at different times.  I am now a “FQAD” person otherwise know as a “Floxie”.

The medication was given appropriately both times as second and third choice for sinusitis and possible bacteria meningitis (it ended up being viral).  I am prone to meningitis and needed to be treated. After two other abx didn’t work, i had to go on a Fluoroquinolone.  My life was saved.  However, it is also ruined.  I was walking up a short flight of stairs, slowly, nothing special, and my Gluteus minimums and my Gluteus medius tore almost completely off my femur.  I was allowed to do nothing and no physical therapy allowed for 7 months.  pain, when not on analgesics was 10/10.  ON FIRE!!  Finally off to the Physical Terrorist and she seemed to somehow cure me.  It is coming back through.

I have concentration difficulties, issues with eyes, i fall asleep sitting up at the dinner table, i cannot remember words, faces, people i know well, EEG shows something as does MRI and have to go through Neurophsych testing, pain head to toe, dx with Fibromyalgia too.  I have never, ever in my life been depressed (unless called for in the case of a loved one dying etc).  I now have depression and am slightly suicidal.  (NEVER EVER that way previously, this is from the Fluoroquinolone.)  I have a chronic fatigue type of issue. I could go on – so many problems.  I have to go have my heart checked now i have issues there  – not sure what.

Please, do a culture.  Insist on a culture.  There may be another drug. I lived, but my life is ruined.  I loved being a nurse.  I cannot even garden now and had to hire a housekeeper.

This is serious!  These Fluoroquinolones are poison.  I don’t really do anything anymore.  i am afraid of running into people who know me and i should know but do not.  That is embarrassing.  I have taken to telling them i am sorry, i have fluoroquinolone toxicity and it has affected my brain.  Will you tell me how i know  you?  Embarrassing as hell, but so far so good, everyone has been nice about it.  When i run into someone who is not, i will probably end up back in my house.

In retrospect, i would rather have risked not taking it and not living.  Yes, it is that bad.

Do not poison your patients.  Tell the docs, they do not know.  Look us up on Facebook by typing in “Fluoroquinolone” in the search bar.  Meet us and see what our lives are like.   One Cipro tablet, one Levoquin can cause this.”

“had reaction to fluoroquinolone but question how many reactions are actually reported to FDA. I know mine wasn’t. Suspect rate of side effects is way higher than reported. also suspect the generic I had releases at a different rate of delivery than the older brand name Levaquin possibly causing reaction as I never had it with brand name in past.”

“After one dose of ciprofloxacin, I developed Achilles tendinitis, first on the right, later on the left. These impaired my mobility for more than one year.”

“Quite a few postal workers presented with today those of us in the “know” call FQ syndrome after prophylaxis for anthrax scare!

There’s a lot out there! Physicians have failed these patients by and large by not reporting these side effects and hence nothing has been done with veracity till now as more and more patients are getting vocal and advocating and demanding answers. The Internet has allowed many suffering to see they are not “crazy” and others are suffering too!”

“Excellent article ,discussing a very important subject.FLUOROQUINOLONES are terrible drugs ! no one can imagine how harmful are they till he suffers one side effect and i refer to the SENSORY NEUROPATHY involing the whole body from face to feet including chest and abdomen.”

“Fluoroquinolones ought to be the absolute last antibiotic of choice in every case. Its’ highly unfavorable safety profile would make me think long and hard before using it.”

“Some doctors still hand these things out like aspirin. I knew they were dangerous, but not this much. This announcement needs very effective publicity – especially to physicians and pharmacists.”

“don’t forget the neurotoxicity ( potential that is ) is not limited to the periphery and that patients with epilepsy should probably be spared the ”quinolone risk” unless options are limited and the treated condition dangerous.”

“FQ’s were brought on the scene with a lot of hype. IMO they have not lived up to the hype that preceded its use. Whatever happened to using Tetracycline for sinusitis, Bactrim for UTI’s. Of course you could go outside the box and use colloidal silver for any and all infections without worry of resistance.”

“I am amazed at how often the quinolones are prescribed when there are safer alternatives. They should not be a first choice!”

“I suffered horribly from Cipro and relate to the fact that MOST physicians have no idea of the wide swath of side effects these drugs are responsible for and unfortunately some of them are so severe they leave the victim with permanent sequelae. So many patients “blown off” by their physicians who either fail or refuse to acknowledge the poison these drugs are. It kills Anthrax.”

“I don’t know why any physician would risk prescribing fluoroquinolones. Tequin almost killed me and I’m not exaggerating. I spent several days close to death in the hospital. Thankfully I’m alive but my hearing and eyesight and blood vessels are permanently damaged and I STILL have other autoimmune, neuropathy and soft tissue issues as well ( since 2003). I spent several days in and out of a ‘ diabetic’ coma and the doctors were no help. No one would listen to me when I told them it was the Tequin that was killing me. Given my sed rate, I was given a Lupus diagnosis. That was the final straw for me and I knew I would die if I didn’t get out of there. When I was coherent long enough to speak to my husband, I told him to unplug me, give me some soda and crackers so that I could gain enough strength to walk out of the hospital. I went home proceeded to do my own research and find the help I needed from friends/colleagues. I was in so much pain all over my body and had to sleep on a hard floor ( with my dogs 😀 ) for two months because the bed was too soft and the slightest strenuous movement was too painful. It took a good year before I was completely pain-free and the tinnitus became tolerable. G-d help anyone in a similar situation that doesn’t have the same level of education to help themselves. These meds should be banned!!!!!!!!!!”

“With the possible exception of darifenacin (Enablex), anticholinergics (antimuscarinics) used in treatment of overactive bladder also increase the risk of QT prolongation and torsade de pointes. Perhaps we should show particular caution in prescribing fluoroquinolones for patients using longterm anticholinergic medications.”

“Maybe physicians should consider side effects more and potential for developing resistance. Cheaper first generation drugs can still be used effectively without going to the big guns for minor infections.Patients don’t always understand potential consequences. Physicians should.”

“It has been more than ten years ago now when the medical director of one of the hospitals I was on staff at told me that flourquinolones was appropriate first-line therapy for a UTI. I vehemently arqued with him to no avail. There was no changing his mind.

Tell me, did he sell out or was the drug manufacturer’s campaign so high powered to convince everyone, except me, that this was appropriate care?”

“Nice article. Warning may also include their effect on sleep, causing insomnia.”

“My father got severe drug reaction with ciprofloxacin in the form of bone marrow failure. I have also been reported cases of bone marrow suppression and skin rashes with ciprofloxacin. It needs further careful observation.”

 

 

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How to Stop Overprescribing Fluoroquinolone Antibiotics

Overprescription of Antibiotics

I found this New York Times article, How to Stop Overprescribing Antibiotics, to be really interesting. Doctors know that antibiotic resistance is a serious problem–the word has gotten out sufficiently, but that knowledge hasn’t done much to change antibiotic prescribing patterns. Doctors are still overprescribing antibiotics, despite knowing that antibiotic resistance poses a significant threat to both modern medicine and human health.

I’m not sure what the root of this overprescribing is. It may be from a lack of knowledge of what ailments antibiotics should be prescribed for (many cases of prostatitis, as well as many sinus infections, aren’t bacterial), tradition (it’s the way it has “always” been done), a notion that antibiotics “can’t hurt,” patient pressure on the physician to do something, or if there’s another root to the problem.

Antibiotic overprescription IS a problem though. It’s a problem not only because of bacterial resistance to antibiotics, but also because of the links between antibiotic use and many of the diseases of modernity, and because some popular antibiotics (FLUOROQUINOLONES in particular, but I’ve heard from people who have been devastated by other antibiotics too) are causing multi-symptom, chronic illnesses that are devastating people’s lives.

Overprescription of Fluoroquinolone Antibiotics

How can we get doctors to stop overprescribing fluoroquinolone antibiotics? The NYT article has some good insight and possible courses of action for floxie advocates.

“we asked a group of doctors to place a signed poster in their exam rooms pledging to follow standard guidelines on antibiotic prescription. This tactic, which pressured doctors to act consistently with their own publicly stated commitments, reduced inappropriate prescribing 20 percentage points relative to doctors in a control group who displayed a poster with generic information about antibiotic use.”

A 20% reduction in inappropriate prescribing is pretty good. At the very least, it’s a good place to start.

Guidelines for Prescribing Fluoroquinolones

What should the guidelines for fluoroquinolone (Cipro, Levaquin, Avelox, Floxin, and their generic equivalents) prescriptions be? My suggestions are:

  • Only prescribe fluoroquinolones for verified infections.
  • Only prescribe fluoroquinolones in life-or-death situations.
  • Only prescribe fluoroquinolones if there is no safer antibiotic that can be tried.
  • Review the warning label with the patient.
  • Review the black box warning with the patient. Notify the patient that black box warnings are the most severe warning possible before a drug is removed from the market.
  • Inform the patient that severe musculoskeletal problems have been experienced post-exposure to fluoroquinolones, including, but not limited to, tendon tears that occur months or years after exposure to the drug has stopped.
  • Note that, per the FDA, “A review of the FDA Adverse Event Reporting System (FAERS) was performed to characterize a constellation of symptoms leading to disability that had been observed during FDA monitoring of fluoroquinolone safety reports. This constellation of symptoms will be referred to in this review as ‘fluoroquinolone-associated disability’ (FQAD). While most of the individual AEs that exist within FQAD are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”
  • Fluoroquinolones cause mitochondrial damage and dysfunction, and mitochondrial damage/dysfunction is linked to many diseases, including autoimmune diseases.
  • Fluoroquinolone effects include serious psychiatric problems.
  • Fluoroquinolones are a likely endocrine disruptor.

I suspect that if those guidelines were in every physician’s office, fluoroquinolone prescriptions would decrease significantly.

Present Alternatives to Antibiotics

The NYT article also notes:

“we showed that doctors tended to prescribe less aggressive medications when such options were presented more prominently (one by one, in a vertical column), with more aggressive options presented less prominently (grouped side by side, in a single category). Previous research suggested that listing alternatives individually made them appear more popular — and therefore more appropriate — than when they were grouped together. And indeed, we found that doctors were roughly 12 percent less likely to order more aggressive medications, such as antibiotics, if these options were grouped together, compared with when they were listed individually.”

I think that’s an excellent idea! Give the physician more information and the patient more options. Sounds great!

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Use Social Pressure and Physician Psychology to Achieve Goals

Another approach mentioned in the NYT article is:

“In one approach, doctors received a monthly email informing them of their performance relative to that of their peers. Those with the lowest inappropriate antibiotic prescribing rates were congratulated for being ‘top performers.’ Doctors who were not top performers were told ‘You are not a top performer.’ The email also included a personalized count of unnecessary antibiotic prescriptions and the count for a typical top performer. This ‘peer comparison’ approach almost completely eliminated inappropriate prescribing: from 19.9 percent in the pre-intervention period to 3.7 percent during the post-intervention period — an 81 percent reduction.”

An 81% reduction is impressive and significant!

Peer comparison is powerful because it taps into doctor’s egos. For fluoroquinolones, I think that guilt should be tapped into as well, and with the low-ranking notification should be a story of someone suffering from fluoroquinolone toxicity. These stories may be anecdotal, but they are real stories of people being devastated by these drugs.

Public Accountability

Another approach to curbing antibiotic use mentioned is:

“whenever doctors prescribed an antibiotic that was not clearly called for by the diagnosis, the electronic health record system asked them to provide a short ‘antibiotic justification note.’ The note would be entered into the patient’s medical record and would be visible to others. Introducing this speed bump into the work flow, along with the prospect of social accountability, reduced the inappropriate prescribing rate from 23.2 percent to 5.2 percent — a 77 percent reduction.”

Public accountability is a good thing. This could work well for curbing unnecessary fluoroquinolone prescriptions.

Start Curbing Antibiotic Overprescription by Curbing Fluoroquinolone Overprescription

The article concludes that, “Taken together, our studies suggest that simple and inexpensive tactics, grounded in scientific insights about human behavior, can be extremely effective in addressing public health problems.”

I think that the methods noted above could effectively cut fluoroquinolone use too.

Maybe trying to curb overuse of all antibiotics is too much to take on. Perhaps taking on overuse of one category of antibiotics at a time is an effective thing to do. I suggest that those who are interested in curbing antibiotic overprescription start with fluoroquinolones.

 

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True Health Made Simple Podcast Featuring Tara

True Health

In episode 31 of the True Health Made Simple podcast, Tara speaks out about her experience with fluoroquinolone toxicity. Please listen and share!

http://truehealthkc.libsyn.com/podcast/031-what-you-need-to-know-abut-the-most-dangerous-class-of-antibioticsfrom-a-patients-perspective

https://itunes.apple.com/us/podcast/true-health-made-simple/id1015211573?mt=2

When Tara sent me the link to the podcast she said, “I just wanted to share – some doctors, like mine – are wanting to get the word out about the dangers of fluoroquinolones so my doctor interviewed me about my story. I let the listeners know to get more info go to floxiehope.com or the QVF website. I think it brings hope to know some doctors really do care.”

It is PHENOMENAL that Tara’s doctors wanted to interview her to spread the word about how fluoroquinolones negatively affected her life, and that Tara was willing to speak out and be interviewed. A HUGE THANK YOU to Tara and her doctors at True Health!

More about Tara can be found on “Tara’s Story – Healing from Levaquin Effects.

Information about True Health can be found on their web site, http://www.truehealthkc.com/, and through their facebook page – https://www.facebook.com/TrueHealthKC.

Thank you for listening and sharing! Great job, Tara!

 

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Antibiotic Brain Fog – Some Possible Solutions

I experienced memory loss, disconnectedness, loss of reading comprehension, and slow-thinking while I was going through fluoroquinolone toxicity. Losing my ability to think, and feeling as if I had lost my ability to do my job (I held onto my job and my employer was kind and patient through the whole ordeal), were truly terrifying. I felt stupid. I was scared that I was stupid, or worse–that I had some sort of permanent brain damage.

Thankfully, those symptoms subsided, and my mind has recovered along with the rest of me. I describe the things I did to heal my brain after fluoroquinolone toxicity in the post, “Healing my Brain After Cipro.” The things that helped my brain to heal are:

  1. Time
  2. Meditation
  3. Sudoku Puzzles
  4. Reading
  5. Writing
  6. Researching

All of those things truly did help me. Each one is a process, not a quick-fix. Being patient and letting the healing hands of time do their magic helped my brain to heal. Meditating every day for a minimum of 20 minutes helped to calm my mind, increase my confidence, give me patience, increase my concentration, and enable me to feel more connected to the world and the people in it. Sudoku puzzles, reading, writing, and researching all helped in that using my brain seemed to make it stronger and more capable.

I wholeheartedly recommend each of those things to everyone who is struggling with brain-fog. They’re helpful, empowering, and they can’t hurt.

I want people to realize that their brains can heal without doing anything drastic, and that with time and use, your floxed mind can heal along with the rest of you.

However, many people look at that list and say, “Those things aren’t going to work for my SEVERE brain fog. I need something more drastic than sudoku puzzles.” Fair enough.

I am risk-averse and, frankly, I’m not a very good biohacker because I’m risk-averse. Therefore, I tend toward gentle, non-invasive, healing methods.

Many of you are willing to take more risks than I am though, and for you, I think that the advice of Dave Asprey (“the world’s most famous biohacker” according to Men’s Fitness Magazine) in his post, “13 Nootropics to Unlock Your True Brain” may be helpful. I highly recommend that each of you read the article because Dave has a lot of excellent insight in it. I’m going to go over some of his recommendations and how they relate to “floxies” in this post.

Dave’s nootropic recommendations:

  1. Modafinil (Provigil), armodafinil (Nuvigil), and adrafinil. I have heard of anyone suffering from antibiotic brain-fog trying these nootropics. If you have something to report about them, please let me know and I’ll add it to this post.
  2. Racetams. Look at the comments on the bottom of the post, “The Mitochondrial Link – Fearless Parent Podcast #81.” The person commenting as “Your Future” gives a lot of interesting information about racetams and mitochondria.
  3. Nicotine. Yes, seriously, nicotine. More information about nicotine can be found HERE. For floxies, it should be noted that fluoroquinolones inhibit CYP1A2 enzymes. Nicotine induces CYP1A2 enzymes. There are significantly safer ways to try nicotine than through smoking or chewing tobacco products and some of those options can be found in “Is Nicotine the Next Big Smart Drug?” It should also be noted that broccoli also induces CYP1A2 enzymes, and it has none of the drawbacks that nicotine has. However, this post is about things that can perk-up your brain, and nicotine can do that while broccoli, unfortunately, can’t.
  4. Amphetamine (Adderall). A floxie friend told me that Adderall helped him immensely. Be careful. Adderall, of course, is not without consequences. Here is the warning label for Adderall – http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021303s015lbl.pdf. Here are patient reviews of Adderall – http://www.askapatient.com/viewrating.asp?drug=11522&name=ADDERALL+10. I wouldn’t take it, but that’s just my extremely biased opinion.
  5. L-theanine. From Ruth’s recovery story on Floxie Hope, “L-Theanine helps my brain to be a less noisy place—it ‘cuts the chatter’ as Dr. Whitcomb says.” More information about Ruth’s experience with L-theanine can be found in the comments on her story.
  6. Bacopa monnieri. Here are some Floxie Hope comments that note how people dealing with FQ toxicity responded to bacopa monnieri. https://floxiehope.com/comment-page-30/#comment-27587https://floxiehope.com/comment-page-46/#comment-37325https://floxiehope.com/ruths-story-cipro-toxicity/comment-page-6/#comment-35332.
  7. LSD. I haven’t heard from anyone who has tried LSD post-flox. If anyone has anything that they’d like to share with me and/or the Floxie Hope audience, please contact me. I find the stories of healings that occur post hallucinogenic drug use to be interesting. As I said though, I’m risk-averse and not eager to try things like LSD.
  8. Unfair Advantage. Unfair Advantage is a Bulletproof product that contains Bio-identical ActivePQQ™ and CoQ10. It enhances mitochondrial function. There is evidence that fluoroquinolones damage mitochondria, and mitochondrial support supplements such as Unfair Advantage may help floxies in multiple ways. I tried Unfair Advantage just before I was on Bulletproof Radio discussing fluoroquinolone toxicity. I was fully healed at the time that I tried it, so my experience may not be as dramatic as the experience of someone who is recently floxed, but I did find that it improved my energy level and concentration.
  9. Bulletproof Upgraded Aging Formula. I don’t know of any floxies who have tried the Bulletproof Upgraded Aging Formula. If you have an experience with it, please contact me.
  10. Forskolin & artichoke extract. I haven’t heard from anyone who has tried Forskolin & artichoke extract. Please contact me if you have an experience with it. As with all of the things mentioned in this section of this post, more information about them can be found on 13 Nootropics to Unlock Your True Brain. “Forskolin” is a very fun word though. Say it ’til you giggle, ’cause laughter really is good medicine. :p

Please do plenty of independent research before you try any of these. They all have their pros and cons and informed consent really is important.

Things like a healthy diet, getting enough sleep, minimizing anxiety, and healing the gut can also be helpful for getting through fluoroquinolone-induced brain-fog. Those things have no negative side-effects, so concentrating on them is highly recommended.

I hope that the things mentioned in this post help you to get your mental capacity back! Please be patient and kind to yourself as you go through the healing process. Healing takes time, and it may take trying a variety of different things before you find things that heal your mind and body. Patience and kindness toward yourself as you go through the healing process certainly can’t hurt, and they will probably even help.

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In Memory of Dr. Jay S. Cohen, M.D.

jaybookcasesm

I am saddened to report that Dr. Jay S. Cohen, M.D. passed away on December 6, 2015.

Dr. Cohen tirelessly advocated for recognition of medication adverse reactions, and specifically focused much of his work on bringing to light the many dangers of fluoroquinolone antibiotics.

Dr. Cohen’s articles about fluoroquinolone toxicity included:

  • New Warnings for Cipro, Levaquin, and other Quinolone Antibiotics
  • Peripheral neuropathy associated with fluoroquinolones
  • Reactions to Cipro, Levaquin, and Other Fluoroquinolone Antibiotics
  • Fluoroquinolone Toxicity Syndrome: A Letter to the Senate Committee on Health, Education & Labor
  • New Warnings for Cipro, Levaquin, and other Quinolone Antibiotics
  • Severe Reactions to Levaquin, Cipro and Other Fluoroquinolone Antibiotics: Are Doctors in Denial?

Many more articles by Dr. Jay S. Cohen can be found on his web site, www.medicationsense.com.

In addition to many articles, Dr. Cohen also published several books including, “How We Can Halt The Cipro & Levaquin Catastrophe: The Worst Medication Disaster In U.S. History.”

Dr. Cohen also consulted with and helped hundreds of people who had been injured by fluoroquinolone antibiotics. He was a powerful advocate and a friend to the community and many people in it. He is missed.

From the Jay S. Cohen M.D. Foundation Web Site:

Jay S. Cohen, M.D., was a nationally respected expert on prescription medications and natural therapies. Dr. Cohen earned his medical degree at Temple University in 1971. After completing his internship, he practiced general medicine and conducted ground-breaking research at UCLA in acupuncture and pain. In 1974, he undertook a residency in psychiatry and psychopharmacology at UCSD, where he was an Adjunct Associate Professor of Psychiatry. He was Chairman of the Medical Advisory Committee of the Erythromelalgia Association, and a Fellow of the American College of Nutrition.

Dr. Cohen’s interest in pharmacology led to independent research on the causes of medication side-effects that result in more than 100,000 deaths and 2 million hospitalizations each year. He noted that a substantial number of people are medication-sensitive, and, starting in 1996, published his findings in eight books and in leading medical journals, as well as articles in publications such as Newsweek, Bottom Line Health, and Life Extension Magazine. His work was featured in The New York Times, The Washington Post, Consumer Reports, Wall Street Journal, Modern Maturity, Women?s Day, and many other national magazines and newspapers. His book, Over Dose: The Case Against The Drug Companies (Tarcher/Putnam, 2001), was favorably reviewed by Publishers Weekly, Library Journal, and the The Journal of the American Medical Association.

In the course of his professional career, Dr. Cohen was featured on more than 100 radio programs across America, including NPR. He presented his findings at conferences of patients, doctors, drug industry executives, and attorneys. During the post-9/11 anthrax scare, his journal article on severe reactions to the class of antibiotics that includes Cipro and Levaquin, triggered a national debate and prompted the U.S. Center of Disease Control to withdraw its recommendation for their use in anthrax-exposure cases.

In 2002, Dr. Cohen was the keynote speaker at the Annual Science Day of the US. Food and Drug Administration’s Clinical Pharmacology Division. He debated top FDA officials on drug safety at several conferences, including those hosted by the American Society for Clinical Pharmacology and Therapeutics, and the Drug Information Association.

Dr. Cohen made his home in Del Mar, CA for over 40 years. He was an avid lover of learning, dogs and the beauty of Del Mar. He is survived by his son Rory Cohen and daughter-in-law Alana Cohen, and a nephew, Hal Cohen.

I had the opportunity to speak with Dr. Jay S. Cohen just a few months before he passed. He was thoughtful, generous and passionate about helping those who have been hurt by fluoroquinolones. He was a wonderful advocate whose work is greatly appreciated by many.

Condolences to Dr. Cohen’s family, friends and loved ones have been expressed extensively in the fluoroquinolone affected community. I echo those condolences. The fluoroquinolone harmed community, and the world, lost a brave and beloved man when Dr. Cohen passed.

He is appreciated and missed.

 

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The Healing Power of the Sea

Lisa Kauai

If I could turn back time, and I had to go through the acute stage of fluoroquinolone toxicity again, I would forego 90% of the doctors’ appointments and I would head straight for the beach. Really–I’m not joking at all. The times that I’ve spent at the beach, and, specifically, in the ocean, have been incredibly healing for me. The sea has given me significant symptom-relief, and I have felt great progress in my healing every time I have visited the ocean post-flox.

The sea is like a giant mineral bath. It is full of magnesium, sodium, and trace minerals (including iodine). Our bodies absorb these minerals through our skin. As most who are reading this know, fluoroquinolones deplete the body of magnesium, iron and other minerals. Soaking in ocean water can help to replace those minerals. Additionally, fluoroquinolones damage the thyroid, and the iodine in the sea may help to repair the thyroid.

I am guessing that most of the benefits I feel while at and in the ocean have to do with the absorption of minerals from the sea into my body through my skin, but there are other benefits to being at the beach too. The times that I’ve gone to the beach post-flox have all been times when I’ve been on vacation, and I have been relaxed while I’ve been there. De-stressing is good for everyone, especially floxies whose GABA neurotransmitters are downgraded, causing them to have difficulty relaxing (though the difficulty relaxing tends to be paired with fatigue – a horrible combination, for sure). I also got tons of vitamin D3 from the sun while at the beach, and vitamin D3, as well as other beneficial things from the sun, are anti-inflammatory and good for the body.

This is a bit woo-woo, but I’ve always felt like being in the water was good for me energetically. It feels as if my nervous system is both energized and relaxed when I’m in the water. In my recent interview with Dave Asprey on Bulletproof Radio we chatted about this. The healing effects of submersion in water for people dealing with multi-symptom, mysterious illnesses, are documented–though I’m not sure of the mechanism through which water heals.

Post-flox, I’ve always felt better in the water. Swimming, even in chlorinated pools, has been healing for me. But I never feel as good in a pool as I do in the ocean. The pool is healing, but the ocean is magical for me. It helps–immensely.

I was never a beach person before I got floxed. I was born and raised in Colorado and I am a mountain girl through and through. I never understood the appeal of beaches–they’re sandy, the sea-water makes my skin sticky, and I both overheat and get sunburned easily. After I got floxed though, I started to appreciate the water because it was healing and energizing for me. About 10 months post-flox I went on vacation to Hawaii and felt the healing power of the sea. Being in the ocean felt AMAZING! Ever since then, I have gotten in the ocean whenever I have the opportunity, and each time it has been invigorating and healing. I guess that I’m a beach/ocean person now–there are worse changes in the world. :p

I hope that fellow floxie friends find the ocean to be as invigorating and healing as I do. The sea is one of my favorite kinds of medicine.

 

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Victory at the FDA

Lisa Testifying at the FDA

 

I wrote a post about the FDA committee hearing about the risks of fluoroquinolones for Hormones Matter. Here it is:

Victory at the FDA for Fluoroquinolone Victims

As Chandler Marrs noted when she posted it on Facebook (BTW, shares are appreciated!):

“Who’s to say the experts know more than the patients? They don’t. This took years of patients speaking out, all the while the experts were silent. I am so impressed with the folks who were ill themselves, but still managed to launch a movement that was finally recognized by the FDA. Though there is still much to do, their stories and their struggles provide a guide to others. Suffering in silence does no one any good. Speak out.”

Indeed. I am very proud of all of the floxies who made this happen. Thank you to all!

 

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FDA Hearing – Victory for Victims of Fluoroquinolones

FDA Hearing Fluoroquinolones

On November 5, 2015, a meeting was held at the FDA’s White Oak campus in Silver Spring, Maryland, for the Antimicrobial Drugs Advisory Committee to discuss, “the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.”

Hundreds of victims of fluoroquinolones from all over the U.S. and Canada came to the meeting to tell their stories of fluoroquinolone toxicity, and the pain and disability that fluoroquinolones brought to their lives. 35 victims and advocates had the opportunity to speak directly to the committee.

The stories of pain, disability, and death caused by Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin were heart-felt and poignant. The pain that these drugs have caused was noted by all those in attendance–including fellow victims, supporters of victims, the media, and the committee.

After deliberation and discussion, the FDA committee decided that the risk and benefits of systemic fluoroquinolone use for treatment of sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections, are NOT sufficiently described in the warning labels for fluoroquinolones. The committee voted almost unanimously in favor of changing the warning labels. WE WERE HEARD! This is a HUGE step in the right direction!

FDA Votes1

The committee is now going to recommend that the FDA update the warning labels to better address the risks and benefits associated with fluoroquinolones. You can read in past posts about how the briefing for this meeting acknowledged that fluoroquinolones are no better at treating the conditions in question than placebos (https://floxiehope.com/2015/10/20/the-fda-notes-that-fluoroquinolones-are-no-better-than-placebos/) and how fluoroquinolones cause a constellation of disabling symptoms (https://floxiehope.com/2015/10/25/an-official-name-fluoroquinolone-associated-disability-fqad/). The entire brief can be read HERE.

An almost unanimous vote by the committee is a HUGE step in the right direction and it is a huge VICTORY that should be celebrated!

THANK YOU to all who came to the meeting testify or to support! You are all appreciated!

In a few days (maybe weeks) the entire meeting will be available to be viewed online. I suggest checking in at the FDA’s web site in a couple of weeks – http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm424449.htm. (I’m not sure that that’s the correct link. If it’s not, I apologize.)

Here are a couple of videos of the testimony provided:

Nicole Delaine:

Michael Kaferly:

More information about Michael’s journey to tell his story can be found at – http://thencamemichael.com/2015/11/08/david-vs-golliath-michaels-fda-testimony/

Here is what I (Lisa Bloomquist) said:

My name is Lisa Bloomquist. I flew in from Denver in order to testify about the damage that ciprofloxacin did to me, and to encourage you to cut the approved uses for fluoroquinolones so that they are only used in life-or-death situations.

In 2011 I took ciprofloxacin to treat an uncomplicated urinary tract infection. I experienced the following symptoms after taking it:

1. Hives all over my body
2. Weakness in my legs to the point that I could barely walk
3. Tightness and pain in my tendons
4. Brain fog
5. Memory loss
6. Autonomic nervous system dysfunction
7. Fatigue
8. Anxiety, fear and other central nervous system symptoms

I was sick for 18 months of my life in my early 30s because of a drug I took to treat a simple urinary tract infection. I have gotten rid of subsequent uncomplicated UTIs with d-mannose and my immune system. It is NOT APPROPRIATE for drugs that are as dangerous and consequential as ciprofloxacin and the other fluoroquinolones to be prescribed to treat simple infections that can be cured with more benign methods.

You will hear the testimony of people who have had much worse reactions than I did. You will hear from people whose lives have been destroyed by fluoroquinolones. The adverse effects of these drugs are severe.

Janssen and Bayer lawyers claim that there is no mechanism for the constellation of symptoms described today. They are wrong.

Fluoroquinolones cause:

  1. Mitochondrial damage which starts a vicious cycle of oxidative stress and further mitochondrial damage. 
  2. Acute fluoride toxicity.
  3. Fluoroquinolones chelate vital minerals from cells, including magnesium and iron. These minerals are necessary for hundreds of enzymatic reactions. 
  4. Fluoroquinolones cause a downgrading of GABA receptors and essentially throw people into protracted benzodiazepine withdrawal.
  5. Fluoroquinolones cause a massive histamine release and mast cell activation. 
  6. They cause collagen synthesis disorders.
  7. They cause microbiome destruction.
  8. All topoisomerase interrupting drugs cause epigenetic damage. They are chemo drugs. Fluoroquinolones should be treated as chemo drugs. They should only be used in life-or-death situations. 

I know these effects, and I can refer you to the studies documenting them. Why don’t you?

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Sherry Reiver:

Good afternoon chair and committee people,

I am so angry after hearing the drug companies but I have my speech written already!

My name is Sherry Reiver and I am 64 years old. I have been sick from FQs in all forms since I was 43. I moved from NY to Charlotte 10 years ago and for 21 years it is difficult to find a dr that will validate that FQs has destroyed my health and life. Each year that goes by, it’s harder for Drs to believe that these affects last so long. Over two years ago during a surgery at Duke against my consent, Floxin soaked GELFOAM PLEDGETS and steroids were placed in my head and I am 200x worse. Lets not kid ourselves, TOPICALS are just as dangerous as any FQs and the Topicals need to be INCLUDED not EXCLUDED from that PN warning the FDA came out with in August of 13.


The perils of the topicals used on children for ear and eye infections should cause great concern and should be researched as well. What are these drugs doing to their little brains and bodies?


This is a bittersweet day for me. Four years ago today, my 93 year old dad died. He FELL at home and was taken to the hospital by a neighbor. By the time my husband and I arrived in Florida, my dad had no idea who we were. They THOUGHT he had pneumonia so they IV’d him with Levaquin. It turned out that he did NOT have pneumonia but he continued to hallucinate for 6 weeks and then died. He was sharp as a tack before Levaquin dripped into his body. He did have an aortic aneurysm for many years which was being watched but it ruptured on November 4th. I would have never connected the AA with FQs until I read this research paper dated October 5th 2015. So here is another RARE side effect that can occur, which it did in my dad’s case. How many others have died from AAs and had taken a FQ drug? It took 10 years for this report to come to light. Was the FDA aware of this research from Tawain?

Do you know that after each cystoscope, Urologists hand out the gift of one Cipro, thank you Bayer, for the “just in case ” scenario? I know this for a fact. Cipro is also given out FREE at pharmacy so therefore it is prescribed more.


Three minutes does not allow me time to talk about my own health issues but understand there are many but Dr. Boxwell’s slides just showed them. We have flares which come and go at the whim of these drugs. It’s the drug that keeps on giving even years later. It has no time constraints, it holds no barriers. Doctors are clueless. We get no warnings, doctors DO NOT report our concerns and they dint read the labels themselves!

NOW EVERYONE, THIS IS THE PART I WAS UNABLE TO READ AS I READ TOO SLOWLY AND MY 3 minutes were up!!!


We are all disabled in different degrees. Don’t judge a book by its cover. I miss my life, i miss reading , I miss being productive and I miss my salary. What I have is not the “aging process” as some Drs have told me, but FQ Toxicity.


Unfortunately there are millions of people who have not connected the dots because they don’t expect an antibiotic to do such harm. Some of these people have died and their families will never know that the FQs were the reason.


Drug reps are NOT the ones who should be educating the Drs on the uses of ANY drugs. The drug companies need to come forward with information they are hiding. Their studies are flawed. PLEASE STOP THE MADNESS of these drugs being handed out so indiscriminately.

Although I am not asking you to ban these drugs, I personally, if on my deathbed would rather die than experience any worsening of my life as it is now.
Thank you for your time. I waited 21 years to be heard!

Rachel Brummert (President of the Quinolone Vigilance Foundation):

FDA_november_rachel02

Note: Rachel’s slide presentation referenced is available HERE.

Good afternoon. My name is Rachel Brummert and I am the Executive Director of the Quinolone Vigilance Foundation. Neither the foundation, nor I, have any financial ties to this hearing.

[SLIDE ONE: Fire pictures/pictures of pills]

Fluoroquinolone antibiotics are incredibly powerful with the capability to save lives when used as a treatment of last resort for life-threatening bacterial infections like anthrax. These antibiotics have equal power to destroy lives when they are prescribed for routine infections like sinus infections and UTIs that don’t need their strength. Just as it is irresponsible to squelch a kitchen fire with the defenses we would mount against a wildfire, likewise, it is reckless to use a fluoroquinolone antibiotic to squelch a routine infection. There are safer, effective antibiotics for the treatment of routine infections in the event that an antibiotic is even necessary.

[SLIDE TWO- Pictures of my ruptures/scars]

I am living proof that the risks in using a fluoroquinolone to treat a routine infection far outweighs the benefits. In 2006, I was prescribed Levaquin for a sinus infection. Within weeks, my achilles tendon ruptured in a parking lot, the first of ten tendon ruptures I’ve suffered over nine years.

[SLIDE THREE- List of my adverse reactions with ICD9 codes]

A first-line of defense antibiotic like Amoxicillin, would have resolved my sinus infection, and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury, which includes a progressive neurodegenerative disorder, from which I will never recover.

With just one prescription, a once-healthy wage-earner, parent, or grandparent – just like you, just like me – can no longer enjoy a reasonable quality of life and now lives with lifelong risks for the development of an illness that is life-threatening.

[SLIDE FOUR- HOW CAN THE FDA HELP?]

What can the FDA do to protect patients from profound, preventable harm? A preventable problem is a fixable problem. The FDA is responsible for protecting and promoting public health through the regulation and supervision of a wide variety of consumer products including prescription medications. Fluoroquinolone antibiotics are causing widespread disability and their overuse is also a contributing factor in the antibiotic resistance epidemic. Antibiotic resistance is such an important issue that there is a White House objective to do something about it. If fluoroquinolones are being prescribed for routine infections which don’t need their strength and they are disabling otherwise healthy patients, and their overuse is leading to an international epidemic, the answer is clear: The FDA must apply its highest level of scrutiny, regulation and surveillance of fluoroquinolones to achieve this shared goal.

Thank you for your time and consideration and for holding this very important meeting.

Linda Livingston:

I have 3 minutes to tell you about my side effects from Cipro, given to me for a simple UTI. I could take an hour trying to describe the two nightmarish months where my breathing was so suffocating I gasped for every single breath. Each night I had to take a pill to sleep and only got an hour if I was lucky. And each night before I took the pill I prayed I wouldn’t wake up. Words cannot describe the rage I feel for the torture I have endured.

I could tell you about the damage to the nerves around my neck that make it feel numb at times and like I am being choked at other times. I could tell you about the horrific olfactory nerve damage that made everything thing in the world asphyxiate me, making me a virtual shut in. I could tell you about my pericardial effusion, blurred vision, terrifying light show, excruciating back pain worse than when I had cracked ribs, or being bedridden for a month and having to have food and non-fluoridated water dropped off, and laundry picked up. I could tell you about my numb fingers and toes, constant bladder pressure, ravaged GI system and 32 pound weight loss in two months, with muscle waste and extreme weakness. There is the swelling over the ulnar nerve, the spasming uncontrollable fingers, the light sensitivity, sound sensitivity, newly acquired food sensitivities, electrical zaps in my knee and arm, popping in my spine and hip, extreme anxiety, depression, crying everyday for 8 months, and suicidal thoughts.

I could tell you about my fears —that my breathing will never again be normal; that my eyes will not improve or even get worse; that my DNA is permanently damaged or my fears surrounding the links to several eye diseases, ALS, Parkinsons and Altzheimers. No one deserves to have their life devastated for a simple UTI!

My life is so different from 9 months ago. I cannot work and worry about how I will pay rent, let along treatments which are not covered by insurance. I can’t meet friends for dinner or happy hour. I have not enjoyed a cup of coffee or glass of wine since January. I can’t exercise like I used to. (I was in incredible shape before this.) My diet is so restricted that there are few places I can go. I am tired all the time, and my anxiety prevents me from doing many things I used to do. My passion is theatre and I may never be able to perform again. There is little joy.

First we are poisoned, then we are left to fend for ourselves because doctors are mostly oblivious to any of the side effects. They are not reading labels or warnings. We are treated with ridicule and derision by the medical community, and then we are financially devastated as well.

If another country did this to us, they would be called war crimes. The pharmaceutical companies have known for decades about the hideous side effects. The FDA has allowed them to inappropriately market these drugs for simple infections. There was recently a GM car recall because of 78 deaths. These drugs may be responsible for up to 300,000 deaths (not to mention all the life altering side effects.) We are not just figures on a share-holders statement. We are people who have been tortured and have our lives decimated. So, why are you even still discussing it at this point?

Linda Landmon:

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My name is Linda Landmon. I’m here today with my husband David, we’re from Dallas Texas and I’m 58 years old.

In 2009 we bought our dream home that we planned to retire in. I had been self employed for 9 years working from home. I was an avid bicycle rider, I enjoyed swimming, entertaining , traveling, spoiling our 2 grandkids and I even had a personal trainer coming to my house twice a week.

Life was good !

But then things changed –

December of 2011 I was diagnosed with a kidney stone.

My Urologist gave me Levaquin “samples ” with no information on the medication or the side effects it may cause. My urine culture was negative for infection.

April of 2012 my Urologist gave me Cipro after a Lithotripsy , again I had no infection.

December of 2012 my Urologist surgically removed my kidney stone and again gave me Cipro. I had no infection this time either.

One week later, January 2013 I went to the ER with Kidney stone pain and I was given one IV of Levaquin and pain medication. My urine culture was negative for infection.

10 days later I went back to the ER with kidney stone pain and I was given 4 bags of Levaquin AND a prescription for Levaquin to take for 10 more days. My urine culture was negative for infection.

Since these medications I’ve been diagnosed with Peripheral Neuropathy, ringing in the ears, high anxiety , a torn rotator cuff, a torn meniscus , which has resulted in needing a total knee replacement , spinal stenosis and tendon damage in my foot. This has all led to depression and I’ve basically become a recluse. For me to speak here today is HUGE !

I’ve had numerous MRI’s , X-rays, steroid shots, I’ve been prescribed, Celebrex , Neurontin, Lyrica, Tramadol and Xanax.

I have a walker, crutches, a leg brace various boots and supports for my foot.

These drugs are prescribed way too often without any proof of infection. I know because it happen to me , FIVE TIMES.

Fluoroquinolones are the only antibiotics I’ve found that carry a Black Box warning and it hasn’t stopped doctors from passing them out like candy.

I didn’t have Anthrax, the Plague OR an infection. I had a kidney stone.

Christabelle Cruz Chajon:

Good afternoon Chair and Committee Members, my name is Christabelle
Chajon. I am 35 years old and live in Washington DC with my husband and
5 year old daughter.

Prior to February 2014, I was loving life. I was healthy and active, and on
no medications. I was a full-time mom with the ability to also work part-time
from home, and enjoyed exercising, hiking, reading, and playing music.

In February 2014, I went to the doctor for a lingering cough. I was
diagnosed with bronchitis and given a 5 day course of Levofloxacin. I
asked at the pharmacy if there were side effects, and was told they were
rare and that tendon damage was only a concern for elderly patients. After
the last pill, I woke in the middle of the night shaking, unable to speak, and
numb from head to toe with my heart racing, and my husband rushed me to
the ER. This happened 3 more times within 6 months after taking
Levofloxacin, and each time I was discharged with nothing more than heart
palpitations.

I also developed many other symptoms including insomnia, intense muscle
and joint pain and weakness, digestive issues, vertigo, fatigue, painful
neuropathy, cognitive impairment, and extreme chemical sensitivities. This
translated into changing my life completely – having to cancel planned
family trips, being unable to carry my daughter when she needed me,
falling asleep unexpectedly while caring for my daughter, being unable to
exercise and enjoy hobbies let alone walk and get out of bed some days.
Food that I ate with no problems before made me sick, and I also lost over
10% of my weight, which is attributed to my body no longer digesting fats
and proteins. Many of these symptoms I still struggle with today, and my
quality of life has declined tremendously. I do not work, and the proper
care and treatments I need are a financial burden on my family. It has
been a frightening struggle to say the least.

But what is most frightening is that most doctors fail to realize that
fluoroquinolones can cause this type of systemic damage. In my search for
help, I even encountered one doctor who was insulted that I considered
that my symptoms were caused by levofloxacin. How can that be when the
connection was obvious as I went from perfectly healthy to unable to get
out of bed and function normally most days?

I joined the Fluoroquinolone Toxicity Group online in the spring of 2014,
which at the time had around 2000 members, all who have suffered from a
constellation of symptoms. That number has more than doubled since
then. It is evident that Fluoroquinolone Associated Disability is not rare.

And per today’s meeting’s briefs, it’s been concluded that antibiotics don’t
make much of a difference on uncomplicated conditions such as sinusitis,
bronchitis, and UTIs; yet, potent fluoroquinolones are being prescribed for
them. The doctors who are inappropriately prescribing these drugs for
simple infections are either unaware of these warnings, or are not taking
them seriously. Limiting the indications to only include serious and lifethreatening
infections, full disclosure to patients about these drugs, and
adding FQAD to the warning labels of fluoroquinolones are absolutely
necessary to stop the countless number of lives damaged and even lost to
these drugs.

If you would like to share your testimony on this site (to archive it, for search engines to find it, or just because you want to) please send it to me through the Contact link above. I am happy to post any and all testimony in any form.

Thank you again to everyone who came to the meeting yesterday! It truly was a huge victory! Great job, everyone!!!

 

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An Official Name: Fluoroquinolone-Associated Disability (FQAD)

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the last post, I noted that the FDA report said that fluoroquinolones have not been shown to be any better than a placebo at treating sinus infections, bronchitis in those with COPD, or uncomplicated urinary tract infections. In this post, I will point out that the FDA has given those suffering from fluoroquinolone toxicity an official name. Per the report:

“A review of the FDA Adverse Event Reporting System (FAERS) was performed to characterize a constellation of symptoms leading to disability that had been observed during FDA monitoring of fluoroquinolone safety reports. This constellation of symptoms will be referred to in this review as ‘fluoroquinolone-associated disability’ (FQAD). While most of the individual AEs that exist within FQAD are currently described in fluoroquinolone labeling, the particular constellation of symptoms across organ systems is not. Individuals with FQAD were defined as U.S. patients who were reported to be previously healthy and prescribed an oral fluoroquinolone antibacterial drug for the treatment of uncomplicated sinusitis, bronchitis, or urinary tract infection (UTI). To qualify, individuals had to have AEs reported in two or more of the following body systems: peripheral nervous system, neuropsychiatric, musculoskeletal, senses, cardiovascular and skin. These body systems were chosen as they had been observed to be frequently involved with the fluoroquinolone reports describing disability. In addition, the AEs had to have been reported to last 30 days or longer after stopping the fluoroquinolone, and had to have a reported outcome of disability.”

That recognition from the FDA is EXCELLENT progress!

I don’t know whether or not FQAD will be put into diagnostic manuals, or if it will be coded for in insurance systems. I hope that those are future steps that will be taken.

So far, in the first 20 pages of the 617 page FDA report, they have noted that fluoroquinolones are no more effective than placebos in treatment of sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. They have also noted that fluoroquinolones can cause a constellation of symptoms across multiple body systems, and that those symptoms can lead to disability.

It is not appropriate to cause, or even to risk, disabling adverse effects through utilization of a drug that is no more effective than a placebo at treating sinus infections, bronchitis in those with COPD, and uncomplicated urinary tract infections. I hope that the FDA changes the recommended uses for fluoroquinolones in recognition of this.

I hope that the naming of FQAD increases recognition of the horrible adverse effects of fluoroquinolones. With recognition, hopefully a more prudent and appropriate approach to use of fluoroquinolones will occur.

Post-publishing edit – While it is a wonderful step in the right direction that the FDA acknowledged that fluoroquinolones can cause a constellation of symptoms that is not adequately noted in the warning label, I may have jumped the gun a bit in calling it an “official” name. FQAD is the term that the FDA is using for the purposes of the November 5th hearing. It is not a diagnostic code that your doctor can look up in his or her diagnostic manuals yet. I hope that it’s a step in that direction, but we’re not there yet. Celebrating the FDA acknowledgement is in order, but we still have a ways to go. I apologize for not being more clear in the post before I originally published it!

 

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The FDA Notes that Fluoroquinolones are no Better than Placebos

For the FDA’s November 5, 2015 meeting to review “The Benefits and Risks of Systemic Fluoroquinolone Antibacterial Drugs for the Treatment of Acute Bacterial Sinusitis (ABS), Acute Bacterial Exacerbation of Chronic Bronchitis in Patients Who Have Chronic Obstructive Pulmonary Disease (ABECB-COPD), and Uncomplicated Urinary Tract Infections (uUTI)” a 617 page report was released by the FDA. You can access it HERE if you want to read it in its entirety.

In the next several posts, I will summarize and comment on the report. The following is post 1 of the summary/commentary:

The report starts by noting that fluoroquinolones have never been shown to be safe or effective treatments for sinusitis, bronchitis for those with COPD, or uncomplicated urinary tract infections. No placebo-controlled trials were conducted when approving fluoroquinolones as treatments for these diseases. Per the FDA:

“Antibacterial drugs approved before the 1980s were in general used as the control antibacterial drugs in NI trials. Because placebo-controlled trials were not used as a basis for the approval of those drugs, a treatment effect of the control antibacterial drugs over placebo had not been clearly established for ABS, ABECB-COPD, or uUTI. Thus, these active-controlled studies may not provide a reliable means to evaluate efficacy of antibacterial drugs for these indications.”

No placebo-controlled studies were used for approval of fluoroquinolones (or any other antibacterial drugs, apparently) in the treatment of sinus infections, bronchitis for those with COPD, or uncomplicated urinary tract infections. It’s just now occurring to the FDA that without placebo-controlled trials, they may not have reliable evidence of the efficacy of these drugs. Ya think?

The report goes on to note that the Cochrane Collaboration concluded the following about treatment of sinusitis with antibiotics:

“The Cochrane Collaboration conducted a review of antibacterial drugs for treatment of clinically diagnosed acute rhinosinusitis in adults and provided this statement in their conclusion: ‘Taking into account antibiotic resistance and the very low incidence of serious complications, we conclude that there is no place for antibiotics for the patient with clinically diagnosed, uncomplicated acute rhinosinusitis’ (Lemiengre, van Driel, et al, 2012).”

Additionally, regarding bronchitis in those with COPD, the FDA report notes that, “Clinical practice guidelines for treatment of ABECB-COPD published by the American College of Physicians stated, ‘Among patients with mild attacks, there were no significant differences between those who received antibiotics and those who received placebo.’”

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The case regarding uncomplicated urinary tract infections is a bit more convoluted, but the report does note that, “In a study (of patients with uncomplicated urinary tract infections) that used ibuprofen as a control, there was no treatment difference on symptom resolution in comparison to an antibacterial drug.”

We rely on the FDA to evaluate drugs to make sure that they are safe and effective. Fluoroquinolones are far from safe—they lead to multiple musculo-skeletal and nervous system adverse effects (most of which are described in the 43 page warning label for Cipro/ciprofloxacin). I was assuming that they were at least effective. It turns out that fluoroquinolones are no more effective than a placebo at treatment of sinus infections, bronchitis or uncomplicated urinary tract infections. (They’re no more effective than a placebo at treating prostatitis either – see THIS POST.) People are getting poisoned and severely hurt by fluoroquinolones–for no good reason. Fluoroquinolones are no more effective than a placebo at treating many of the conditions they are prescribed for, and people would be far better off taking a sugar-pill than they are taking a topoisomerase interrupting chemo drug that is no more effective than a placebo.

The FDA approved fluoroquinolones for use in treatment of sinus infections, bronchitis for those with COPD, and uncomplicated urinary tract infections based on the assumption that they were safe and effective, not on actual studies showing that assumption to be true. They are not safe, and they are no better than a placebo for treatment of these conditions. For more than 30 years, the FDA has been using false assumptions and faith, rather than evidence established by placebo-controlled trials, as the basis for approving dangerous drugs for treatment of benign infections that the body can fight off using its immune system (or a placebo).

The mantra of “all drugs have side-effects” is often spewed by people who think that side-effects are acceptable. But with any veil of acceptability comes the assumption that dangerous drugs are at least effective. Fluoroquinolones aren’t even effective at treating sinusitis, bronchitis or uncomplicated UTIs—diseases that they are prescribed for thousands of times every day. They are no better than a placebo at treating those conditions. They are neither safe nor effective and people would be better off taking snake oil than they are taking ineffective drugs that deplete mitochondrial DNA and lead to tendon ruptures, permanent peripheral neuropathy, serious central nervous system adverse effects, and more.

Fluoroquinolones are neither safe nor effective. Every person who has been hurt by a fluoroquinolone taken to treat sinusitis, bronchitis or an uncomplicated UTI was hurt because of the FDA’s ineptitude and their inability to realize that antibiotics need to go through placebo-controlled trials just like every other drug.

This situation, where the FDA approves unsafe and ineffective snake-oils to be sold by the pharmaceutical juggernauts as long as they are labeled as “antibiotics,” is only going to get worse with the passage of the 21st Century Cures Act. The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. In an op/ed article in the New England Journal of Medicine, it is noted that:

“The proposed legislation would make immediate changes with respect to new antibiotics and antifungals by enabling their approval without conventional clinical trials, if needed to treat a ‘serious or life-threatening infection’ in patients with an ‘unmet medical need.’ In place of proof that the antimicrobial actually decreases morbidity or mortality, the FDA would be empowered to accept nontraditional efficacy measures drawn from small studies as well as ‘preclinical, pharmacologic, or pathophysiologic evidence; nonclinical susceptibility and pharmacokinetic data, data from phase 2 clinical trials; and such other confirmatory evidence as the secretary [of health and human services] determines appropriate to approve the drug.’ Antimicrobials approved in this manner would carry disclaimers on their labeling, but there is no evidence that such a precaution would restrict prescribing to only the most appropriate patients. If passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use. The bill gives the secretary of health and human services the authority to expand this nontraditional approval pathway to other drug categories as well, if “the public health would benefit from expansion.”

Don’t think for a second that the FDA is keeping snake-oils off the market. They’ve been allowing drugs that are more dangerous than snake-oils, and no more effective, to be sold to the American public for years.

I hope that they at least try to undo some of the damage done in the November 5th meeting. We shall see.

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Advocacy Opportunity – FDA Meeting to Discuss Fluoroquinolones

ADVOCACY OPPORTUNITY 

The FDA (Food and Drug Administration) is holding a meeting on November 5, 2015 to discuss the benefits and risks of fluoroquinolones. Per the FDA notice, the agenda for the meeting is:

“The committees will discuss the risks and benefits of the systemic fluoroquinolone antibacterial drugs for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis in patients who have chronic obstructive pulmonary disease, and uncomplicated urinary tract infections in the context of available safety information and the treatment effect of antibacterial drugs in these clinical conditions.”

They are opening the meeting for public testimony and if you are in the Silver Spring, Maryland area I encourage you to attend the meeting and to testify at it. (I would love to go, but I’m in Colorado, so not exactly nearby.)

They are also accepting written testimony. Please send your story/testimony to Jennifer Shepherd, the contact person, by October 22, 2015. Jennifer’s contact information is:

Jennifer Shepherd, RPh.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: AMDAC@fda.hhs.gov

PLEASE take the time to tell your story to the FDA. The adverse effects of fluoroquinolones are too severe for it to be appropriate for them to be used for sinusitis or uncomplicated urinary tract infections. This is your opportunity to share your story directly with the FDA, and the committee that determines how fluoroquinolones are used.

More information can be found in these announcement links –

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm465275.htm

https://www.federalregister.gov/articles/2015/10/01/2015-24836/joint-meeting-of-the-antimicrobial-drugs-advisory-committee-formerly-known-as-the-anti-infective

THANK YOU!!!

 

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The Next Time Will be Worse: Cross-Reactivity of Fluoroquinolones

On every single warning label for each fluoroquinolone it says that if a person has experienced an adverse reaction to a quinolone, they should not be exposed to quinolones again.

The Cipro/ciprofloxacin warning label says:

“Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.”

The Avelox/moxifloxacin warning label says:

“Contraindications: Known hypersensitivity to AVELOX or other quinolones.”

The Ciprodex ear drop warning label says:

“CIPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.”

Yet these warnings are disregarded regularly. I often hear from people who tell their doctor that they are allergic to Levaquin, and their doctor prescribes them Cipro. Or they tell their doctor that they are allergic to Cipro, but are still prescribed ofloxacin eye drops. There seems to be a lack of understanding of the cross-reactivity or one quinolone with all other quinolones.

The lack of knowledge and understanding is not because of lack of documentation. In an article in Current Pharmaceutical Design entitled “An Update on the Diagnosis of Allergic and Non-Allergic Drug Hypersensitivity,” it is noted that, “cross-reactivity among quinolones at both the IgE- and T-cell level is clinically well documented. Therefore, patients with hypersensitivity reactions to any quinolone should not be re-exposed to any antimicrobial agents of that class.”

Additionally, in The European Journal of Allergy and Clinical Immunology’s article, “Cross-reactivity between quinolones,” it is noted that, “We conclude that cross-reactivity between quinolone seems to be very important, and avoidance of any quinolone should be recommended to any patients who has suffered an allergic reaction to one of these drugs.”

When I told my doctors at Kaiser Permanente that I wanted fluoroquinolones to be put in my chart as a drug allergy, they couldn’t do it, because “fluoroquinolones” are a class of drugs, and they could only enter individual drugs into their system. In order to get all fluoroquinolones in my chart, I had to list every fluoroquinolone separately, because if I just said that I was allergic to Cipro, they would still give me Levaquin, or Avelox or Floxin. That’s a bit ridiculous seeing as it says ON THE WARNING LABEL that if someone has a history of hyper-sensitivity to one quinolone, they should avoid exposure to other quinolones. I’m sure that it’s easier said than done, but couldn’t there be some sort of cross-population of information that takes the “clinically well documented” cross-reactivity of quinolones into consideration? If someone has experienced a severe adverse reaction to Floxin, they shouldn’t take Levaquin—it’s not that difficult a concept. But systems are not currently in place to recognize, much less track or prevent, cross-reactivity or contraindications between drugs.

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If a person experiences a severe adverse reaction to a fluoroquinolone and they feel as if a bomb has gone off in their body and mind, they know that they have had an adverse reaction to a quinolone. Going through one severe adverse reaction to a quinolone is enough for most people, and they are likely to realize that they should never take a quinolone again. However, there are many people who experience mild-to-moderate adverse reactions to quinolones who don’t realize that they have had an adverse reaction in the past.

For the people reading this who may have taken a fluoroquinolone in the past but haven’t had a severe adverse reaction, I encourage you to think about your health history. After taking Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin, or Floxin/ofloxacin, did you experience any of the following?

Insomnia
Anxiety
Loss of endurance
Muscle twitches
Tendon tears or ruptures
Depression
GI issues
Mild peripheral neuropathy

Those are all Warning Signs of fluoroquinolone toxicity. After the first time I took ciprofloxacin I had a twitchy eyelid and intermittent stomach cramping. I wish I had known that those symptoms were adverse reactions to the ciprofloxacin, and that I had known that I could no longer tolerate it. If I had known that I had experienced an adverse reaction to ciprofloxacin in the past, and if I had known that the warning labels say that people who have had a bad reaction shouldn’t take the drug again, I wouldn’t have taken it again and I would have avoided full-blown fluoroquinolone toxicity. There are a million “if only” scenarios around my adverse reaction to ciprofloxacin. I can’t turn back time and change anything though. I can only move forward and warn people. I hope that people heed my warning, and connect bizarre, seemingly innocuous symptoms like anxiety and sprained elbows, to the fluoroquinolone they took to treat an infection, and that they avoid future use of fluoroquinolones.

 

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Quinolone Vigilance Foundation (QVF) Update

Quinolone Vigilance Foundation (QVF) Update

I asked Rachel Brummert, President of the QVF, to update the January, 2014 post about the QVF – https://floxiehope.com/2014/01/29/the-quinolone-vigilance-foundation-qvf/.  It turns out that a lot of updating needed to be done, so I’m making the update a whole new post.  Thank you to everyone involved with the QVF for all your efforts!  

There is a non-profit, charitable foundation devoted to raising awareness about the dangers of fluoroquinolone antibiotics and fluoroquinolone toxicity, advocating for victims, educating the medical community, and to funding research on fluoroquinolone toxicity. It is called The Quinolone Vigilance Foundation (the QVF) – www.saferpills.org.

Following is some information about the QVF:

History and Purpose

The QVF is a registered 501(c)(3) non-profit foundation established in 2009 and Incorporated in 2012. Its founders sought to establish professional credibility by reviewing the existing scientific literature that addressed adverse reactions from fluoroquinolones; recruited and networked medical researchers; and stimulated new research into this poorly understood issue. The QVF branched out in 2014 to educating the medical profession.

“Our mission is four-fold: Educating the medical profession about fluoroquinolones, advocating for victims of fluoroquinolone toxicity, raising awareness in the United States and abroad, and research. Advocacy, education, and research go hand in hand and gives a complete picture of the problem. Helping victims already affected and getting ahead of it so damage doesn’t happen in the first place is something we are very passionate about and we work hard to achieve,” explains Rachel Brummert, Executive Director of the QVF.

Advocacy and Outreach

  • In the spring of 2014, the QVF began educating doctors in local practices and major medical centers.
  • QVF has held six fundraisers since 2013 to raise funding for advocacy and education, and for the University of Rochester research study.
  • QVF sells awareness merchandise:

www.cafepress.com/quinvigil

https://www.bravelets.com/bravepage/fluoroquinolone-life-qvf

http://konectidy.com/charity/quinolone-vigilance-foundation/

  • QVF is in early stages of bringing in two new research studies.
  • QVF attended two FDA Hearings
  • QVF continues to work with media outlets to warn viewers of the dangers of fluoroquinolone antibiotics. We provide information to reporters and assist in finding victims to be interviewed.
  • QVF receives many requests from doctors offices and pharmacies for brochures and awareness cards to display. We also offer free brochures to anyone who wishes to pass them out in their communities. In addition, we offer downloadable brochures on our website under the Resources tab for anyone who wishes to print them out themselves. http://www.saferpills.org/print-download/
  • Author, actor and international speaker Josh Rivedal asked QVF to participate in the i’Mpossible Project and the upcoming book The i’Mpossible Project: Volume 1 Reengaging With Life, Creating a New You due to be released on January 13, 2016 and available for pre-order on September 16, 2015. Per an agreement with the publisher, 100% of proceeds made from our contribution to the book will be donated to QVF and no person shall personally gain from the book. QVF has been approached by several media outlets to discuss the book and about the topic of fluoroquinolone toxicity. The book will be available in paperback and e-book, at major bookstores like Books A Million, Barnes & Noble and Amazon, and online as an ebook at BN.com, Kindle, iTunes, Nook, and Google Books. The i’Mpossible Project is a collection of powerful stories. The stories in this first volume are all about overcoming obstacles, reengaging with life, and creating new possibilities. Among the other authors are Academy Award Winner James Lecesne, and actress Ali Stroker of Fox’s GLEE. We are honored to participate and to bring fluoroquinolone toxicity awareness to an international audience.
  • QVF produces awareness videos which can be readily shared to spread awareness and participates in podcasts and radio shows.

Television Media stories featuring QVF volunteers

Arizonahttp://www.abc15.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Arizonahttp://www.azcentral.com/videos/news/local/arizona/2014/11/04/18450053/

Michiganhttp://www.wxyz.com/news/local-news/investigations/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Indianahttp://www.theindychannel.com/news/u-s-world/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Florida- http://www.wptv.com/money/consumer/experts-top-antibiotic-carries-hidden-side-effects-not-listed-on-the-label

Ohiohttp://www.wcpo.com/news/health/healthy-living/levaquin-popular-antibiotic-carries-side-effects-not-listed-on-label

Californiahttp://www.10news.com/news/investigations/patients-experts-popular-antibiotics-could-cause-permanent-damage-11242014

Georgiahttp://www.wsbtv.com/videos/news/channel-2-investigates-complaints-about-popular/vDDZZS/

Georgiahttp://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/

Georgiahttp://www.wsbtv.com/videos/news/another-widow-says-medication-killed-her-husband/vDD6mw/

Californiahttp://losangeles.cbslocal.com/2015/03/04/southland-firefighter-says-popular-antibiotic-stripped-him-of-his-career/

Missourihttp://www.kctv5.com/story/28170151/fda-evaluates-popular-antibiotic-that-patients-say-makes-them-sicker

Virginiahttp://wric.com/2015/04/21/8news-investigates-could-this-antibiotic-permanently-damage-your-health/

Virginiahttp://wric.com/2015/05/20/8news-investigates-doctors-left-in-dark-about-prescription-drug-dangers/

Articles featuring QVF

Care Novate: http://carenovatemag.com/personal-account-prescription-destruction-black-box-warning/

United Kingdom: http://born-in-newyork.com/ciprofloxacin-antibiotic-resistance/

Washington Post: http://www.washingtonpost.com/national/health-science/it-pays-to-read-the-warnings-when-you-open-up-a-prescription/2015/08/03/a29e11b4-d70e-11e4-b3f2-607bd612aeac_story.html?tid=hpModule_9d3add6c-8a79-11e2-98d9-3012c1cd8d1e

Tulsa World: http://www.tulsaworld.com/opinion/idelle-davidson-the-risky-business-of-taking-antibiotics/article_bcce562a-bd78-5d92-b156-6926115be61c.html

Connecticut- http://www.courant.com/consumer/hc-ls-antibiotics-drug-reaction-20150821-story.html

Italy: http://m.ilgazzettino.it/m/gazzettino/articolo/NORDEST/1270894

QVF Staff/Volunteers

The QVF is comprised of a board of directors, non-board volunteers, and ambassadors/advocates from all over the world: The United States, Canada, Ireland, the United Kingdom, Belgium, Australia, Algeria, and Italy.

The current volunteer staff positions are as follows:

Board

Rachel Brummert – Executive Director and President

Matthew Arnold – Vice President

Donna Schutz – Assistant Director and Ambassador Coordinator

Leslie Day – Corporate Secretary

Christina Manthos -Sorrell – Treasurer

Dr. Deanna Minkler – General Board Member

Dr. Joe Hudak – General Board Member

Non-board

Victoria Chiovare – Assistant Fundraising Director

Jenny Frank- Public Relations Director

All QVF positions are staffed by volunteers who generously donate their time and talents to promote the mission and values of the organization. No one within the organization receives compensation of any kind.

More information about the QVF can be found on www.saferpills.org and you can sign up for quarterly newsletters to keep up to date on QVF projects and activities.

To donate to QVF: donations@saferpills.org. All donations are tax deductible.

 

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Healing is a Journey

One day I was doing Crossfit and the next I could barely walk.  The flox bomb went off in me quickly.  I had a slightly delayed reaction – my body exploded 2 weeks after I finished taking ciprofloxacin (when I started taking ibuprofen and when I got my period – both the contraindicated NSAID and the hormonal shifts probably played a role) – but once the fuse was lit, the bomb detonated quickly.  Suddenly I was unable to do the things I used to do with ease.  I was barely able to walk, much less hike up a mountain.  I was barely able to think, much less go to school while working full-time.  

In some ways I’m grateful that I didn’t fall apart gradually.  If my health had declined slowly I may have thought that I was just getting old, or I may have thought that I was coming down with one of the named mysterious diseases like fibromyalgia or CFS/ME.  I did think I had an autoimmune disease, not knowing whether or not they could strike a person suddenly.  All of the tests for autoimmune diseases came back negative though, and it wasn’t long before I realized that my symptoms were those of fluoroquinolone toxicity.  Because I went from well to sick so suddenly, it was not only plausible, it was clear that I was poisoned.  

But having my health suddenly stolen from me was terrifying, traumatic and, frankly, it felt unfair.  I had worked out regularly.  I had always eaten decently.  I was only 32.  I was healthy and strong.  How could I get poisoned?

The thing that felt most unfair about the situation was that there was no magic pill to put me back together again.  A pill could mess me up, but there wasn’t a pill to heal me.  I could suddenly be sickened, but I couldn’t suddenly get well.  Doctors could prescribe pills that could tear apart my cells, but they didn’t seem to have any advice for how to put my cells back together.  

It sucked.  

It sucks, and is unfair, that there isn’t a pill (whether it be a pharmaceutical or a supplement) that can reverse the damage done by fluoroquinolones.  It sucks, and is unfair, that the damage can be done suddenly, but the repair – the healing – takes time.  

As unfair and sucky as it is, the process of healing is not instantaneous – it takes time.  Healing is a process that requires patience, compassion, forgiveness, surrender, hard work, luck, nutrition, movement, tenacity, support, and love, among other things.  Perhaps the time healing takes is an opportunity to gain those things.  We all need more patience, compassion, forgiveness, surrender, hard work, luck, nutrition, movement, tenacity, support, and love in our lives.  Getting poisoned is a lousy way to come by those things.  But while you’re going through the trenches of fluoroquinolone toxicity, I encourage you to look around for those silver linings.

It took me a long time to get over anger about my health being stolen from me by Bayer/Cipro.  I’m still not completely over it and maybe I never will be.  But finding some appreciation for the journey has been helpful.  It has been healing.  

Healing is a journey, and the journey is healing.  They go hand in hand.  

I have learned that lesson.  Perhaps it’s what the storm is about.

“And once the storm is over, you won’t remember how you made it through, how you managed to survive. You won’t even be sure, whether the storm is really over. But one thing is certain. When you come out of the storm, you won’t be the same person who walked in. That’s what this storm’s all about.” -Haruki Murakami

 

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Fluoroquinolone Toxicity Video of News Stories

Chris Jones made this WONDERFUL video –

https://www.youtube.com/watch?v=XgTiGhFrBgc

He posted it with the following instructions:

Over the last year there have been many news stories about fluoroquinolones. I made a video to highlight these stories. I am asking you all to please help me do a few things.

1. Watch it many times to get the view count up.

2. Like the video.

3. Leave a comment on it in YouTube. ( the news stories comments helped a lot, but once the story is gone it is a lot harder for new people to see them). These comments will help people who get floxed years from now.

4. Share as many time as possible.

After the comments and views are high. I will be emailing it to major news stations, talk shows, politicians, the FDA, and I recommend you send it to the doctor who rx you this poison.

Thank you everyone who had the courage to do a news story. I know how hard it was. And thank you to everyone behind the scenes who put them together.

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Progress Gained in Fluoroquinolone Toxicity Awareness

A lot of awareness of fluoroquinolone toxicity has been gained in the last few years.  In 2011, when I got floxed, the biggest facebook support group for “floxies” had about 600 members, news stories about fluoroquinolone toxicity were few and far between, and people seemed to be reluctant to share information about fluoroquinolones on their social media accounts. Today, the biggest facebook support group for floxies has almost 4,000 members (and many people have come and gone, so there have been more than 3,400 people who are aware enough of fluoroquinolone toxicity to join the group), news reports about the dangers of fluoroquinolones seem to come out on a weekly basis, and people are screaming about the dangers of fluoroquinolones in every way they can – through their social media accounts, telling their personal stories on web sites, commenting on news stories, and through talking to their families, friends, doctors and anyone else who will listen to them.

We’re making progress. We’re getting louder and stronger.

Even the FDA, the slow-moving behemoth that it is, has made some movement toward acknowledging the dangers of fluoroquinolones. In 2013 the warning label for fluoroquinolones was updated to note that PERMANENT peripheral neuropathy is a possible adverse effect of fluoroquinolones. The FDA stated that this change to the warning label was because of a review of AERS (Adverse Event Reporting System) data that found that many people were reporting disabling peripheral neuropathy as an effect of fluoroquinolones. AERS reports are patient reports. The FDA is listening to our screams.

The warning label change prompted a slew of lawsuits against Bayer (the maker of Cipro and Avelox) and Johnson & Johnson (maker of Levaquin), that hopefully will give some people justice and compensation for the harm that fluoroquinolones have done to them. Just having the door opened for justice is a step in the right direction – it’s progress.

In September, 2014 Dr. Charles Bennett filed two Citizen’s Petitions with the FDA asking them to change the fluoroquinolone warning labels to note “mitochondrial toxicity” and “psychiatric adverse effects.” The FDA’s response to those petitions is still pending, but the petitions themselves are valuable, both in that they are communications with the FDA, and that they give victims of fluoroquinolones credibility.

More than 60 news stories about the dangers of fluoroquinolones have aired in the last year. Each of these news stories was made possible by people reaching out to the news media. They wouldn’t have happened without people advocating for themselves and speaking up. With each news story, the word spreads about the dangers of fluoroquinolones, and the more people are aware of fluoroquinolone toxicity. With awareness of the dangers of fluoroquinolones comes avoidance of them, and that’s certainly progress.

One of the most influential news-stories about fluoroquinolones was “Local woman says popular antibiotic killed her husband” which aired on WSB-TV Atlanta. It had more than 135,000 social media shares, and Levaquin prescriptions in the Atlanta area dropped dramatically after it aired. It not only successfully spread the word about the devastating effects of fluoroquinolones, it changed prescription rates for fluoroquinolones. That’s huge! (Though, of course, it is horrible that Chris Dannelly lost his life. My eternal condolences to his family.)

A lot of progress in awareness of fluoroquinolone toxicity has been made through social media. When I first got floxed, people didn’t mention fluoroquinolone toxicity on their social media pages. There seemed to be a lot of silence, and even shame, around it. Now there are people who share information about the dangers of fluoroquinolones on their social media accounts regularly. With every “share” or “like” people are reached and progress toward awareness is made. Every little step rolls the ball in the right direction and gives us momentum. A huge THANK YOU to everyone who shares information about fluoroquinolone toxicity with their social network!

While it is sad to see the devastation that fluoroquinolones bring to every floxed individual, it is nice to see that the awareness of fluoroquinolone toxicity is reaching people, and that they are reaching out for support on facebook. The community of floxies helping and supporting each other in The Fluoroquinolone Toxicity Group has grown significantly. Each person who connects their health problems to fluoroquinolones is a step toward general awareness of fluoroquinolone toxicity. Everyone who joins The Fluoroquinolone Toxicity Group realizes the dangers of fluoroquinolones for themselves and their loved ones. Of course, I hate to hear of people getting hurt by fluoroquinolones, but with each new member to the group, awareness and support are gained.

Even this site has gained a lot of momentum. When it launched in 2013, Floxie Hope was getting about 5,000 visitors per month (which I was THRILLED with). Now 30,000+ visitors per month view Floxie Hope. I’m proud to be part of the movement toward awareness of the devastation that fluoroquinolones bring, and I hope to be part of movements to study fluoroquinolones and limit their use.

All of us who are telling our stories, supporting each other, and sharing information about fluoroquinolone toxicity are making progress. Thank you to all of you!

Admittedly, we have a long way to go before paradigms about the safety of fluoroquinolones shift in the general population.  There are still some doctors who are giving FQs out like candy.  There are still people who deny adverse effects of fluoroquinolones that are listed on the warning labels.  There is still a lot of research that needs to be done.  But progress has been made in the last year, and this post is to celebrate that progress.  Good job, friends!  Keep going!

 

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Babies!

The floxie community is experiencing a baby boom. There are a lot of first-time moms and dads in the floxie community and I wanted to say CONGRATULATIONS to all of them!

The babies that have recently been born to floxie moms and dads are healthy, happy and beautiful. They are blessings to their parents and the world.

When I first got floxed, I was concerned about how my fluoroquinolone toxicity reaction would affect any future offspring I might have. It’s a worry that a lot of people of child-bearing age have. I was comforted by people like Briean, who has had 2 healthy children post-flox. I hope that all floxies find comfort in the smiling faces of the babies who have recently been born to floxed moms and dads. So far, all of the kids of floxies seem to be healthy and unaffected by the fluoroquinolone toxicity of their parents. Whatever made us vulnerable to getting floxed, or changes to our bodies as a result of getting floxed, don’t seem to be hurting the next generation.

Of course, it’s impossible to tell how a person will end up, or how healthy she or he will be in the long run, when she or he is only 6 months old, but, so far so good, as far as the health of babies born to floxed parents goes.

I have written about my fears about the intergenerational effects of fluoroquinolones (it seems like a particularly horrible idea to give topoisomerase interrupting drugs to people of child-bearing age). But it should be noted that my fears about the potential intergenerational effects of fluoroquinolones are just fears at this point—they have not been validated by any studies of intergenerational effects of fluoroquinolones. I whole-heartedly think that studies should be done. But the anecdotal evidence of lots of healthy, smiling babies being born to floxed parents, that is available now, is worth a lot. I hope that the healthy babies grow into healthy children and healthy adults—presumably, they will.

Should you, or I, or anyone else who has been floxed, have kids? I don’t think that there is any reason why a past history of fluoroquinolone toxicity should be taken into consideration when deciding whether or not to have kids, seeing as the babies who have been born to floxies are healthy. It should depend on whether or not this looks like something you want to sign up for:

Seriously? You do? Well, go for it then. 🙂

The knowledge that floxies have about gene SNPs, nutrition, antioxidants, etc. may even make their children more healthy than they would have been. Floxies know to avoid fluoroquinolones, and they will certainly never let their children get floxed. Avoiding fluoroquinolones is certainly a step in the direction of long-term health and happiness.

Again, CONGRATULATIONS to the floxie parents out there! Your babies are gorgeous! I hope that they live a long, happy, healthy, wonderful life and that they bring healing joy to your life! Give all your little ones a hug from me, and know that I wish them all the joy, love and health this world can bring.

Xoxo

-Lisa

 

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Fluoroquinolones Deplete Iron and Lead to Epigenetic Changes

In my ciprofloxacin toxicity recovery story I note that:

I take a low dose iron supplement – only 5 mg. – daily. The brand of iron supplement that I use is Pur Absorb, but I’m guessing that other low-dose iron supplements will work equally well. Within just a couple days of starting taking the iron supplement, my energy levels increased dramatically. I could walk a mile without being exhausted afterward. In addition to improving my energy level, the iron supplement seems to make my muscles and tendons more supple and malleable. When my tendons are feeling tight, a dose of iron helps to loosen them up – within just a couple hours. Too much iron is really bad for you, so please be careful with supplementing it (ask your doctor, yada yada), but it helps me immensely.”

I’ve always wondered why iron helped me to recover from fluoroquinolone toxicity. In some ways, it didn’t make sense – iron is an oxidant (according to a doctor friend, it’s a bit more complicated than that, and in some situations iron can be an antioxidant and in others it can be an oxidant), and antioxidant supplements are what help most floxies. Also, iron is a component of the Fenton Reaction, and the Fenton Reaction is where, “Iron(II) is oxidized by hydrogen peroxide to iron(III), forming a hydroxyl radical and a hydroxide ion in the process. Iron(III) is then reduced back to iron(II) by another molecule of hydrogen peroxide, forming a hydroperoxyl radical and a proton. The net effect is a disproportionation of hydrogen peroxide to create two different oxygen-radical species, with water (H+ + OH–) as a byproduct.” Basically, iron can “donate or accept free electrons via intracellular reactions and help in creating free radicals.” Free radicals are ROS. Some of the nastiest ROS are created in the Fenton Reaction – hydroxyl radicals and hydroperoxyl radicals. According to “Oxidative Stress Induced by Fluoroquinolones on Treatment for Complicated Urinary Tract Infections in Indian Patients,” fluoroqinolones increase the production of ROS, and it has been postulated (by myself and others) that the mechanism for fluoroquinolone toxicity is an excess of ROS wreaking havoc on all systems of the body.

So, why did iron make me feel so much better?

It’s a question that has perplexed me for years.

Answers to that question can be found in the article, “Non-antibiotic effects of fluoroquinolones in mammalian cells” which was published in the July, 2015 issue of The Journal of Biological Chemistry. In this post I will highlight some of the more interesting findings from “Non-antibiotic effects of fluoroquinolones in mammalian cells.” All excerpts from the article are quoted and italicized.

Here we show that the FQ drugs Norfloxacin, Ciprofloxacin, and Enrofloxacin are powerful iron chelators comparable to Deferoxamine, a clinically-useful iron chelating agent.”

Fluoroquinolones suck iron out of (chelate) cells just as well as drugs that are meant to suck the iron out of cells (Deferoxamine). Iron is an essential mineral that is critical for transporting oxygen throughout the body. Chelation of iron from cells can be detrimental to health in multiple ways including, “delayed cognitive function, poor exercise performance and lowered immune function. In children, iron deficiency anemia can cause psychomotor and cognitive abnormalities resulting in future learning difficulties.

We show that iron chelation by FQ leads to epigenetic effects through inhibition of α-ketoglutarate-dependent dioxygenases that require iron as a co-factor.”

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Iron depletion leads to adverse epigenetic effects through inhibition of iron-dependent enzymes. This is a very big deal – Fluoroquinolones can change genetic expression (epigenetics) in human cells. Later in the article it is noted that, “This is the first study to show global epigenetic changes induced by FQ antibiotics.” It had been previously postulated in “Epigenetic side-effects of common pharmaceuticals: A potential new field in medicine and pharmacology” (2009) that all fluoroquinolone adverse effects were the result of epigenetic changes, but “Non-antibiotic effects of fluoroquinolones in mammalian cells” describes the first study of human cells that shows epigenetic changes caused by fluoroquinolones. Epigenetics wasn’t even a notion, much less a field of study, when the FDA approved fluoroquinolones, drugs whose mechanism of action is, “inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.” Think about that next time you pick up a drug from the pharmacy and assume that it’s safe because the FDA approved it.

Dioxygenases are enzymes that are necessary for aerobic life. Fluoroquinolones inhibit α-ketoglutarate-dependent dioxygenases, which require iron as a co-factor.  Depletion of α-ketoglutarate-dependent dioxygenases leads to changes in how genes are expressed.

Fluoroquinolones were also found to inhibit several demethylases, “enzymes that remove methyl (CH3-) groups from nucleic acids, proteins (in particular histones), and other molecules. Demethylase enzymes are important in epigenetic modification mechanisms. The demethylase proteins alter transcriptional regulation of the genome by controlling the methylation levels that occur on DNA and histones and, in turn, regulate the chromatin state at specific gene loci within organisms.” FQs were found to inhibit “Jumonji domain histone demethylases, TET DNA demethylases, and collagen prolyl 4-hydroxylases, leading to accumulation of methylated histones and DNA, and inhibition of proline hydroxylation in collagen, respectively. These effects may explain FQ-induced nephrotoxicity and tendinopathy.” (emphasis added).

Many possible mechanisms for the tendinopathy and compromised collagen integrity caused by fluoroquinolones have been proposed. It has been suggested that fluoroquinolone caused destruction of connective tissues are due to metalloprotease (MMP) malfunctions, magnesium depletion, and the NO/ONOO cycle. In “Non-antibiotic effects of fluoroquinolones in mammalian cells” it is asserted that iron chelation, and the inhibition of enzymes that utilize iron, are behind the fluoroquinolone-caused musculoskeletal adverse effects:

These results suggest, for the first time, that FQ treatment can cause unanticipated epigenetic effects. Moreover, we suggest that the well-established linkage between FQ treatment and tendinopathy reflects impairment of collagen maturation by FQ. We suggest that it is the inhibition of collagen 4 prolylhydroxylases by FQ mediated iron chelation, and repression of collagen P4H1 and LH1 transcription that underlies the peculiar tendinopathy side effects of FQ antibiotics.”

And:

FQ are potent iron chelators capable of inhibiting 2-KG dependent dioxygenases because of the crucial role of iron in the active site. We show that FQ treatment inhibits collagen maturation. Prolyl 4- hydroxylase and lysyl hydroxylase are iron dependent enzymes essential for the post-translational modification of collagen. Both play central roles in collagen maturation through hydroxylation of proline and lysine residues to mediate collagen cross-linking. Covalent crosslinks are required for the tensile strength of collagen fibers (64). We suggest that it is iron chelation by FQ that accounts for suppressed collagen hydroxylation, giving rise to tendinopathies.”

And:

Additionally, suppression of HIF-1α can have drastic effects on vascularization and energy metabolism in connective tissues, contributing to decreased blood flow in an already hypoxic and avascular tissue. We suggest that these three insults – inhibition of prolyl and lysyl dioxygenases, reduction of P4HA1 and LH1 mRNA levels, and reduced tendon vascularization upon HIF-1α depletion – together account for FQ induced tendinopathies.”

To sum up the excerpts, fluoroquinolones chelate iron from cells, this leads to inhibition of iron-dependent enzymes, which lead to epigenetic changes that result in collagen malformation and tendinopathies. It should also be noted that fluoroquinolones chelate other minerals, including magnesium, from cells, and magnesium-dependent enzymes are inhibited by fluoroquinolones as well.

All doctors and researchers, and the FDA, should note that in chelating necessary minerals from the body, fluoroquinolones are not only inhibiting necessary enzymatic reactions, they’re also changing genetic expression, and that the long list of severe adverse effects of fluoroquinolones may be due to adverse expression of genes. Neither long-term, nor intergenerational effects of fluoroquinolones are currently known.

So… what should floxies do with this information? Personally, I supplement iron and I find that it helps me immensely. Not everyone can, or should, supplement iron though. Too little iron is bad, but too much is also harmful. The prudent thing to do is to get your iron levels tested and to supplement if necessary under the care of your doctor.

When I corresponded with Dr. Maher, one of the authors of “Non-antibiotic effects of fluoroquinolones in mammalian cells,” he noted that, “I would simply emphasize that what we demonstrate in this work involves human cells grown in culture, and lab conditions, and we want to make it clear that these are findings of potential mechanisms of fluoroquinolone antibiotics that could be relevant for patients, but we provide no direct data related to human patients or treatments. Further studies will be required to understand if these or related effects actually occur in people.”

I am thankful to Doctors Badal, Her and Maher for their work on “Non-antibiotic effects of fluoroquinolones in mammalian cells!” Of course, caution should be used when drawing conclusions from their results. Though I shouldn’t draw conclusions about how FQs react in a complex human body from how human kidney cells react in a petri dish, I don’t think that it’s completely out of line to say that the potential implications of this research are huge. The chelation of minerals from cells by fluoroquinolones may be leading to epigenetic changes in the people who take fluoroquinolones. What this means for their health is not currently known.

The epigenetic adverse effects of fluoroquinolones were found to be reversible by exposing the floxed cells to iron, and studies have shown that magnesium, vitamin E, MitoQ and NAC can reverse some of the effects of fluoroquinolones, so please have hope, hang in there, and take your mineral supplements (under the supervision of your doctor, yada, yada).

 

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Treating Fluoroquinolone Anxiety

Free-floating, often severe, anxiety is a common symptom of fluoroquinolone toxicity.

Fluoroquinolones thoroughly mess up GABA neurotransmitters, and GABA “plays the principal role in reducing neuronal excitability throughout the nervous system.”  Here are a few articles that describe how fluoroquinolones negatively affect GABA – Article 1, Article 2, Article 3.

To put what fluoroquinolones do to GABA neurotransmitters into a framework, they basically throw people into protracted benzodiazepine withdrawal.  People who have gone through benzodiazepine withdrawal at any time in life should NEVER take a fluoroquinolone.  See “Benzodiazepine tolerance, dependency, and withdrawal syndromes and interactions with fluoroquinolone antimicrobials” for more information about how fluoroquinolones affect people who have a history of benzodiazepine use and withdrawal.

The things that help people through protracted benzodiazepine withdrawal may be helpful for floxies too.  GABA neurotransmitters and receptors have been iatrogenically damaged by both drugs, and they need to heal.  From what I understand, the Ashton Manual has a lot of good information in it about healing from benzodiazepine withdrawal.  Support sites like www.benzobuddies.org may also be helpful.

A very interesting review of supplements to treat anxiety (specifically benzodiazepine induced anxiety, but the advice is applicable to floxies too) can be found through this link –

http://www.longecity.org/forum/topic/54028-treating-anxiety-safely-effectively/

Additionally, Ruth has researched and written extensively about fluoroquinolone induced anxiety and I suggest reading her story – https://floxiehope.com/ruths-story-cipro-toxicity/ and listening to her podcast – https://floxiehope.com/2015/01/07/the-floxie-hope-podcast-episode-6-ruth-young/.  She also wrote some very interesting and insightful comments on my story starting about June 9, 2015 – https://floxiehope.com/lisas-recovery-story-cipro-toxicity/comment-page-13/#comments.

Ruth mentions supplementing uridine in her story:

I also have found that uridine works really well when I get that horrible insomnia and nothing else is helping. Uridine has it’s own receptors in the brain, so maybe it is a way floxies can bypass GABA receptor damage. I cannot prevent a relapse with it. I take it after the relapse starts, 500-750 mg with a fish oil capsule to help it work better. It’s something to have in reserve for those times you just want to crawl out of your own skin and you need to get some rest. Taking it every day did nothing for me. It has to be timed just right, at the moment that every time I’m starting to fall asleep symptoms are getting more intense and now I’m standing there by my bed with my skin just burning, knowing I am not going to sleep. A couple uridine and I’m out within thirty minutes.

It has recently come to my attention that uridine helps to reduce epileptic seizures and that increases free GABA, thus it has a calming influence. I have found it to be useful.

The things that helped me to get through cipro-induced anxiety are: 1. Acupuncture, 2. Meditation, 3. Stress reduction – especially flox related stress – that meant getting off the internet.

I went through a recent period of pain that induced anxiety. Kava helped me a lot. The longecity article recommends against kava, and I think that their concerns are valid. It is only for short-term use and it probably isn’t best for people who have had a history of benzo withdrawal. Personally, I’ve never had a benzo and I only needed to use kava for a short period of time.  It was a life-saver during the time I used it. Be careful with it though.

There is a vicious cycle when it comes to fluoroquinolone toxicity symptoms and anxiety.  Fluoroquinolone toxicity symptoms lead to stress and anxiety (it’s a pretty reasonable to be stressed and anxious when you’re suddenly in pain, you can’t move but when you do you tear tendons, you lose your memory, and suffer from chronic insomnia – to name just a few symptoms of fluoroquinolone toxicity), stress and anxiety negatively affect the autonomic nervous system (ANS) and lead to dysautonomia, ANS damage leads to more fluoroquinolone toxicity symptoms, which leads to more stress, and so on, and so on.

I don’t think that fluoroquinolone toxicity is “just” anxiety, but I do think that anxiety makes every symptom of fluoroquinolone toxicity worse.  I also think that there is nothing to be trivialized about anxiety.  It’s not a choice.  It’s the central and autonomic nervous systems going completely hay-wire, and both stress and anxiety can lead to serious health problems.

I know that anxiety makes you not want to do these things, but I also suggest trying really hard to do the simple things that make you healthy and happy. Sleep plenty. Enjoy your food. Laugh a lot. Be social. Hang out with a pet and/or children. Those things are healthy and they are healing. They’re easier said than done, but they’re certainly worth a try.

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In my opinion, it’s imperative for floxies to get stress and anxiety symptoms under control.  Neither stress nor anxiety are easy things to control, and, like I said earlier, it’s not a choice – it’s GABA neurotransmitter damage – but anything that can be done to reduce stress and anxiety will help the GABA neurotransmitters to heal, and will help the ANS and CNS to normalize.

Fluoroquinolone induced anxiety can be crawl-out-of-your-skin horrible, but it does get better.  Hang in there, my friends.

 

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FQ Toxicity Awareness Wall of Fame

 

Some very influential medical professionals (doctors, scientists, pharmacists) have been speaking out about fluoroquinolone toxicity.  This post is to thank them and let them know that they are greatly appreciated!

Dr. Charles Bennett, M.D., Ph.D., M.P.P.

Dr. Bennett has filed two petitions with the FDA to get them to change the warning labels for fluoroquinolones.  One of the petitions is to get the FDA to add Psychiatric Adverse Events to the Levaquin/levofloxacin warning labelThe other is to have the FDA add “Possible Mitochondrial Toxicity” to the Levaquin Label.  The petitions have increased the credibility of “floxies” and have been featured in many of the news stories about fluoroquinolones.  If the FDA responds to the petitions by changing the warning labels for fluoroquinolones, it will be a huge “win” for those who have been hurt by fluoroquinolones.

Dr. Bennett has spoken out about the dangers of fluoroquinolones on many of the recent news stories about fluoroquinolone toxicity.  Here is one news story that Dr. Bennett was interviewed for:

Many others can be found on https://floxiehope.com/fluoroquinolones-links-resources/

THANK YOU DR. BENNETT!

Dr. David Perlmutter, M.D.

Dr. Perlmutter spoke out about the dangerous effects of fluoroquinolones in the NBC 2 Fort Myers, Florida report, “NBC2 Investigators: Thousands call for stronger antibiotic warning.”  Dr. Perlmutter noted in his interview that fluoroquinolones are drastically overprescribed, and, “I’d say there’s very little doubt it was directly related to taking those medications” when asked about his patient Jamie Laura’s debilitating symptoms.

Additionally, Dr. Perlmutter made this video about fluoroquinolones and peripheral neuropathy:

Dr. Perlmutter has more than 325,000 facebook “likes.”  He is a very influential neurologist who has been featured on The Dr. Oz Show, Dr. Mercola’s web site (and books), and other highly visible places.  He is the author of Grain Brain: The Surprising Truth about Wheat, Carbs, and Sugar–Your Brain’s Silent Killers and Brain Maker: The Power of Gut Microbes to Heal and Protect Your Brain–for Life.  For someone of Dr. Perlmutter’s status to be acknowledging fluoroquinolone toxicity is HUGE!

THANK YOU DR. PERLMUTTER!

Dr. Jay S. Cohen, M.D.

Dr. Cohen has been tirelessly studying fluoroquinolone toxicity, and writing articles about the myriad of adverse effects of fluoroquinolones, for more than a decade.  He is the author of the following articles:

Dr. Cohen recently said, “In my 40+ years in pharmacovigilance, FQs (fluoroquinolones) surpass Vioxx and Thalidomide in the degree of permanent harm done.”  If that’s not screaming from the rooftops, I don’t know what is.

THANK YOU DR. COHEN!

Dr. David L. Katz, MD, MPH, FACPM, FACP

Dr. Katz is a specialist in Internal Medicine and Preventive Medicine/Public Health, and the author of a textbook on evidence-based clinical decisions.  He noted in his Huffington Post article, “Your Doctor’s Knee-Jerk Reflex: How Not to Get Kicked” that:

“I recently saw and began treating a patient for the fluoroquinolone syndrome. Within just a couple of weeks, I heard from a friend who had classic symptoms of it as well, following treatment with Levaquin. In both cases, there was a valid indication for antibiotic use. But there was also good reason to doubt the need for such a high-powered, broad-spectrum antibiotic in both cases. Often, the easiest way for a busy clinician to be sure to “cover the bases” with an antibiotic is to go after a fly with an elephant gun. The collateral damage can, predictably, be considerable; a consequence of knee-jerk prescribing.”

That is very nice acknowledgement of fluoroquinolone syndrome and noting of the over-use of these consequential drugs.

THANK YOU DR. KATZ!

Suzy Cohen, RPh

According to her bio on Amazon, “Suzy Cohen, America’s Pharmacist is the author of 8 books. She is the co-host of a free worldwide event which you can watch from home called The Thyroid Summit.com.  Suzy has been a licensed pharmacist for more than 24 years, and she is a Functional Medicine practitioner. In addition to writing a syndicated health column, Dear Pharmacist, for the last 16 years, which circulates to millions of readers each week, Suzy hosts a medical minute on Know the Cause television. She has a Huffington Post blog. You may have seen her on the The Dr. Oz Show, The View, The Doctors, The 700 Club and Good Morning America Health. She has appeared in hundreds of magazines and television shows nationwide. Her books are translated into various languages. Memberships include: The American College for Advancement in Medicine, The Institute of Functional Medicine, The American Academy of Anti-Aging Medicine American Pharmacist’s Association, International Lyme and Associated Diseases Society.”

In her November, 2014 post, “I’m Going to Ruffle Feathers but I’ll Tell You Anyway” she noted:

“A few popular antibiotics affect DNA similar to some chemotherapy agents. If you’re sensitive to them, you could pay a neurological price that causes sudden and serious neuropathy and degrees of brain damage. The drugs that the FDA is concerned about belong to the fluoroquinolone class, and already have a black box warning for increasing the risk of tendon ruptures. But I’m telling you that more reports have come in with accusations of neurological damage. Personally, I would only use these for life-threatening infections that were unresponsive to older regular antibiotics. I wouldn’t take them if I had a regular old urinary tract or sinus infection.”

It is awesome that someone as influential as Suzy Cohen acknowledges the dangerous effects of fluoroquinolones!

THANK YOU SUZY COHEN!

Dr. Beatrice Alexandra Golomb, MD, PhD

Dr. Golomb’s C.V./resume lists her many accomplishments – http://www.fqstudy.info/Fluoroquinolone_Effects_Study/About_Dr._Golomb.html

Dr. Golomb is conducting the Fluoroquinolone Effects Study through the UC San Diego School of Medicine.

A description of Dr. Golomb’s involvement with the “floxie” community can be found on www.myquinstory.info, “Fluoroquinolone Academic Research Update – Dr. Beatrice Golomb UCSD.

Dr. Golomb’s work brings an enormous amount of credibility to those who are floxed.

THANK YOU DR. GOLOMB!

Dr. Joseph Mercola, M.D.

Dr. Joseph Mercola  is a “family physician and founder of www.mercola.com with more than thirty million monthly views that help people find safe and inexpensive nutritional, lifestyle and exercise options to dangerous drugs and surgeries.” (per his bio on Amazon).  He has over ONE MILLION facebook “likes” and is highly influential.

The following articles about FQ toxicity were published on www.mercola.com:

Dr. Mercola has been instrumental in getting the word out about the dangers of fluoroquinolones.

THANK YOU DR. MERCOLA!

The medical professionals mentioned above are very influential (and even famous).  There are many other physicians who are speaking out about the dangers of fluoroquinolones, but who don’t quite have the reach that fame gives those mentioned above.  Their voices are important too though, and I encourage everyone to click on the following document that describes fluoroquinolone toxicity in the words of the doctors affected by it:

http://fluoroquinolonethyroid.com/wp-content/uploads/2014/11/FQ-Adverse-Effects-In-Their-Own-Words-from-Physicians.pdf

There are many other doctors (and other medical professionals) who have spoken out about the dangers of fluoroquinolones and I, as well as others in the “floxie” community, appreciate each and every one of them!  There is no way I could possibly include them all in this post and I will likely do a follow-up post featuring others who are speaking out about the dangerous effects of fluoroquinolones.  For now, a huge THANK YOU goes out to Dr. Bennett, Dr. Perlmutter, Dr. Cohen, Dr. Katz, Dr. Golomb, Dr. Mercola and Suzy Cohen.  You are all appreciated!

A list of doctors who have been favorably reviewed by fellow floxies can be found HERE.

We’re getting to the tipping point of awareness about fluoroquinolone toxicity.  Soon, it will only be the willfully ignorant doctors who don’t read warning labels or research articles, who don’t watch the news (story 1, story 2, story 3, story 4), and who don’t listen to their peers or their patients, that claim that fluoroquinolones are “safe and effective” drugs.  They may be effective, but they’re far from safe.  The doctors listed above know it, patients know it, all physicians should know it.

 

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Studies Link Topoisomerase Interrupting Drugs to Autism

It has recently been discovered that, “chemicals or genetic mutations that impair topoisomerases, and possibly other components of the transcription elongation machinery that interface with topoisomerases, have the potential to profoundly affect expression of long ASD (autism spectrum disorder) candidate genes.”  (1)

Topoisomerases are enzymes that are essential for DNA and RNA replication and reproduction.  Without topoisomerase enzymes, DNA and RNA supercoiling fail to resolve correctly during cell division and gene transcription.  Topoisomerases are like oil to the DNA and RNA replication engine—making the process go smoothly.  Without topoisomerases, DNA and RNA supercoiling jams up and “over-heats,” causing transcription errors.  Topoisomerases are also “integral for gene expression, as they resolve DNA supercoiling that is generated during transcription.” (1)

DNA_replication_en.svg

Many pharmaceutical drugs inhibit topoisomerases.  Most of these drugs are chemotherapeutic agents such as topotecan, a drug used to treat various forms of cancer.  The most widely used topoisomerase inhibitors are fluoroquinolone antibiotics—Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin—drugs used to treat simple urinary tract, prostate, sinus and other infections.  The fluoroquinolone antibiotics that are in wide use were first patented in the late 1980s and their use increased steadily from then until now, with 26.9 million prescriptions for orally and IV administered fluoroquinolones written in 2011. (2)  A similar number of topically administered fluoroquinolone prescriptions have been written, and though orally and IV administered fluoroquinolones are not recommended for use in children because they cause cartilage lesions in juvenile animals (3), topically administered fluoroquinolones are approved for use in children as young as 6 months of age (4), and are regularly given to young children in the form of ear and eye drops.

Autism rates have been skyrocketing since the 1980s, with the most recent numbers out of the CDC stating that one in 68 American children is on the autism spectrum. (5)

prevalence-graph1

It is likely that a variety of environmental and genetic components has led to the staggering figure of 1 in 68 American children on the autism spectrum.  Studies have focused on vaccines (and there are vaccine injured children), but epidemiological studies have suggested that factors other than vaccines are likely at play.  Birth control pills, acetaminophen, antidepressants and other categories of drugs have been pointed to for their deleterious effects on the human brain, and their possible contributions to the increasing number of people on the autism spectrum.

STUDY SUMMARY AND IMPLICATIONS

In this article, I will go over some studies that point to topoisomerase interrupting drugs as a potential cause of autism.  The studies are out of the University of North Carolina at Chapel Hill—“Topoisomerases facilitate transcription of long genes linked to autism,” published in Nature (as well as the corresponding author manuscript), and “Topoisomerase 1 inhibition reversibly impairs synaptic function,” published in PNAS.  I will link these studies to the fact that fluoroquinolones are also topoisomerase interrupters.

The mechanism of action for Cipro/ciprofloxacin is:

“The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.”(6)

The mechanism of action for other fluoroquinolones—Levaquin/levofloxacin, Avelox/moxifloxacin, Floxin/ofloxacin, and their generic equivalents—are the same.

Why anyone thought that it was a good idea to give DNA disrupting chemotherapeutic drugs to children with ear infections is beyond my comprehension, but it happens every day.

Fluoroquinolone use has gone up hand in hand with autism rates.  As critics of all possible causes of autism are quick to point out, correlation does not mean causation.  While that criticism is true, the causes of autism are undoubtedly correlated with autism rates, and thus correlations should be examined.

The articles that I will be reviewing note that topoisomerase interrupting drugs profoundly affect the expression of genes related to autism.  A large number of the genes that have been found to be related to autism are particularly long and complex, and are related to neurotransmitter synaptic function and neurodevelopment.  The expression of these long genes is affected by topoisomerase interrupting drugs, as one may expect when noting that topoisomerases are necessary for gene transcription, and longer genes can more easily get mis-transcribed when exposed to topoisomerase interrupting drugs.

fluoroquinolone-lawsuit-banner-trulaw

Topoisomerase enzymes are expressed throughout the adult brain, and thus the connections between topoisomerase inhibiting drugs and neurodegenerative diseases should be explored along with connections between those drugs and autism.  It is noted in “Topoisomerases facilitate transcription of long genes linked to autism” that, “Our findings suggest that chemicals and genetic mutations that impair topoisomerases could commonly contribute to ASD and other neurodevelopmental disorders.”

Both “Topoisomerases facilitate transcription of long genes linked to autism” and “Topoisomerase 1 inhibition reversibly impairs synaptic function” examine the effects of topotecan, a topoisomerase 1 (TOP1) inhibitor, on autism related genes and synapses.  Studies of the effects of fluoroquinolones, topoisomerase 2 and 4 interrupters, have not yet been published.

It should be noted that the existing studies have looked at nuclear gene expression, and that the effects of topoisomerase interrupting drugs on the expression of mitochondrial and microbiome genes have not yet been explored.

The implications of “Topoisomerases facilitate transcription of long genes linked to autism” and “Topoisomerase 1 inhibition reversibly impairs synaptic function” are potentially huge given the wide-spread use of topoisomerase interrupting fluoroquinolones, both directly in humans and in agriculture.  If fluoroquinolones are conclusively linked to autism, their use in children and people of child-bearing age (exactly how gene expression is affected by topoisomerase interrupting drugs, and what the intergenerational effects may be, are not yet known) should be prohibited—effective immediately—regardless of what the average physician who knows little about the effects of topoisomerase inhibitors on gene expression thinks about the “excellent safety record” of fluoroquinolones as a class of drugs.

As a person who has been hurt by ciprofloxacin, a fluoroquinolone antibiotic, I am not without bias—but I do not think that it’s unreasonable to assert that all topoisomerase interrupting drugs should be strictly limited—especially if they’re connected in any way to autism or neurodegenerative diseases.

STUDIES LINKING TOPOISOMERASE INTERRUPTING DRUGS TO AUTISM

Topoisomerases facilitate transcription of long genes linked to autism” concludes that:

“Our data suggest that chemicals or genetic mutations that impair topoisomerases, and possibly other components of the transcription elongation machinery that interface with topoisomerases, have the potential to profoundly affect expression of long ASD candidate genes.  Length-dependent impairment of gene transcription, particularly in neurons and during critical periods of brain development, may thus represent a unifying cause of pathology in many individuals with ASD and other neurodevelopmental disorders.”

This conclusion has multiple levels of significance.  It involves a shift in thinking about ASD as either a genetic disorder or an environmentally caused disorder, to noting the interplay between genes and the environment (epigenetics).

The study is also significant in that it notes that genes that encode synaptic function and neurodevelopment, that are also related to autism, are particularly long and complex.  Those long and complex genes aren’t transcribed properly when topoisomerase enzymes are inhibited via pharmaceuticals.  When topoisomerase interrupting drugs impair gene transcription, expressions of long genes become impaired.

Whether or not the silencing of expression of particularly long genes through topoisomerase interrupting drugs is a possible unifying cause of autism spectrum disorders depends on the prevalence of topoisomerase interrupting drugs in our environment.  Topotecan, the topoisomerase 1 interrupter that was studied, is a chemotherapeutic drug that is only used in cancer patients, and is rarely used in pediatric patients.  Fluoroquinolone antibiotics, on the other hand, are topoisomerase interrupting drugs that are used commonly in the general population, including the pediatric population, and are even used in agriculture and thus are present in the food we eat, the soil our food is grown in and even the water we drink.

More than 20 million prescriptions for fluoroquinolones—topoisomerase interrupting drugs—have been written each year for more than two decades.  One is hard pressed to find an adult American who has not had at least one fluoroquinolone prescription in his or her lifetime.  Fluoroquinolone use has gone up hand in hand with incidence rates of autism.  As noted earlier, that correlation does not mean causation, but if topoisomerase interrupting drugs in our pharmacies and environment are a unifying cause of ASD (and other neurodegenerative diseases of modernity), fluoroquinolones would need to be the causal factor, not prudently used chemo drugs like topotecan.  Studies looking into this line of thinking are pending, and the similarities between fluorquinolones and chemotherapeutic topoisomerase interrupters have not escaped the attention of the researchers looking into the relationships between topoisomerases and autism.

The UNC researchers found that, “topotecan reduced expression of nearly all extremely long genes in mouse cortical neurons,” (1) and were able to reproduce the same results in human neurons.  Interestingly, not only was the expression of long genes suppressed, “topotecan increased expression of a majority of genes that were <67 kb in length, although the magnitude of this increase was very small for most genes.” (1)  The expression of long genes, those genes that are involved in encoding neural synapses, was downgraded, whereas the expression of shorter genes was up-regulated.

An example of a particularly long gene that is related to ASD whose expression is altered by topotecan is “Ubiquitin-protein ligase E3A (Ube3a), a gene that affects synaptic activity and that is deleted or duplicated in distinct neurodevelopmental disorders (Angelman syndrome and autism, respectively)” (7)  Ube3a is “normally expressed only from the maternal allele in neurons and regulates synaptic function.” (1)  However, in cells that have been exposed to topoisomerase interrupting drugs, the paternal allele of Ube3a is transcriptionally upregulated.  “Duplication of the chromosomal region containing maternal Ube3a is frequently detected in individuals with autism.”

Other particularly long genes are affected by topoisomerase interrupting drugs include:

“many genes down-regulated by topotecan are associated with synapses, cell adhesion, and neurotransmission.  Moreover, a number of those down-regulated long genes are associated with autism, including Neurexin-1 (Nrxn1; 1059 kb), Neuroligin-1 (Nlgn1; 900 kb) and Contactin-associated protein 2 (Cntnap2; 2,241 kb), genes that are well known to regulate inhibitory and excitatory synaptic function.” (7)

I wasn’t able to find any scholarly articles about the effects of fluoroquinolones on Nrxn1, Nlgn1 or Cntnap2.  However, it is hypothesized in “Epigenetic side-effects of common pharmaceuticals: A potential new field in medicine and pharmacology,” that all adverse reactions to fluoroquinolones are due to epigenetic mechanisms:

“The quinolones are a family of broad-spectrum antibiotics. They inhibit the bacterial DNA gyrase or the topoisomerase IV enzyme, thereby inhibiting DNA replication and transcription. Eukaryotic cells do not contain DNA gyrase or topoisomerase IV, so it has been assumed that quinolones and fluoroquinolones have no effect on human cells, but they have been shown to inhibit eukaryotic DNA polymerase alpha and beta, and terminal deoxynucleotidyl transferase, affect cell cycle progression and function of lymphocytes in vitro, and cause other genotoxic effects. These agents have been associated with a diverse array of side-effects including hypoglycemia, hyperglycemia, dysglycemia, QTc prolongation, torsades des pointes, seizures, phototoxicity, tendon rupture, and pseudomembranous colitis. Cases of persistent neuropathy resulting in paresthesias, hypoaesthesias, dysesthesias, and weakness are quite common. Even more common are ruptures of the shoulder, hand, Achilles, or other tendons that require surgical repair or result in prolonged disability. Interestingly, extensive changes in gene expression were found in articular cartilage of rats receiving the quinolone antibacterial agent ofloxacin, suggesting a potential epigenetic mechanism for the arthropathy caused by these agents. It has also been documented that the incidence of hepatic and dysrhythmic cardiovascular events following use of fluoroquinolones is increased compared to controls, suggesting the possibility of persistent gene expression changes in the liver and heart.”(8)

Also, it has been known since 1996, when “Delayed Cytotoxicity and Cleavage of Mitochondrial DNA in Ciprofloxacin-Treated Mammalian Cells” was published in Molecular Pharmacology, that fluoroquinolones deplete mitochondrial DNA.  The article states, “The loss in mtDNA was associated with a delayed loss in mitochondrial function. Here, we report that the 4-quinolone drug ciprofloxacin is cytotoxic to a variety of cultured mammalian cell lines at concentrations that deplete cells of mtDNA.” (9)  Nuclear gene expression is linked to mitochondrial functioning and, “Mitochondria generate signals that regulate nuclear gene expression via retrograde signaling,” (10).  Fluoroquinolone induced mitochondrial DNA damage may lead to changes in nuclear DNA expression.

Fluoroquinolones are also known to affect neurotransmitters, particularly GABA neurotransmitters.  (11)  GABA neurotransmitters are responsible for regulation of inhibitory and excitatory synaptic function.  It is noted in “Topoisomerase 1 inhibition reversibly impairs synaptic function” that, “GABA-A receptor subunits are encoded by long genes.” And that, “multiple synaptic proteins encoded by long genes including cell adhesion molecules linked to autism and GABA receptor subunits, are depleted in topotecan-treated neurons.”

GABA receptors

Given that GABA receptors are critical for inhibitory and excitatory synaptic functioning, examining the role between GABA receptors, topoisomerases, topoisomerase inhibiting drugs, and attention deficit hyperactivity disorder (ADHD) is certainly warranted.  Many individuals with ASD also display symptoms of ADHD, and the interactions between GABA and glutamate receptors may be why many individuals with ASD find symptom relief through a gluten and casein free diet that is low in glutamate.

As the title of “Topoisomerase 1 inhibition reversibly impairs synaptic function” indicates, it was found that “the synaptic effects of topotecan are reversible” upon washout of the drug.  However, the complexity of neurotransmission is acknowledged in the discussion section of the article, where it is noted that, “adding back one synaptic cell-adhesion molecule would not likely restore the protein levels of all affected synaptic cell-adhesion molecules as well as multiple GABA-A receptor subunits.” It is also noted that, “transient TOP1 (topoisomerase 1) inhibition has the potential to impair brain function reversibly, whereas a persistent change in TOP1 activity has the potential to disrupt neurodevelopment and promote neurodegeneration.”  With limited exposure to a topoisomerase interrupting drug, the neurological effects appear to be reversible.  However, persistent exposure can cause more persistent harm.

Adult patients with fluoroquinolone toxicity syndrome often note that they were able to tolerate fluoroquinolones without experiencing adverse effects prior to getting “floxed.”  This tolerance threshold may indicate that fluoroquinolones somehow accumulate in cells and that the adverse effects of fluoroquinolones are amplified with each exposure.  It is also possible that mitochondrial DNA needs to cross over a damage threshold before resulting in adverse effects.  More about this can be found in the post, “The Fluoroquinolone Time Bomb – Answers in the Mitochondria.”

IS IT POSSIBLE THAT FLUOROQUINOLONE ANTIBIOTICS ARE RESPONSIBLE FOR MANY CASES OF AUTISM? 

The possibility hasn’t been explored, despite the documented effects of fluoroquinolones that line up with many of the symptoms and effects of autism.  In addition to the correlation between fluoroquinolone prescription rates and autism rates, and the points noted above about topoisomerase interrupting drugs changing the expression of autism related genes, fluoroquinolones also damage mitochondria (12)—and mitochondrial damage has been linked to autism (13) .  Fluoroquinolones also cause cellular leakage (14) and depletion of minerals (15) that are necessary for synthesis of minerals and vitamins that (deficiencies of) have been linked to autism (16).  Fluoroquinolones, as powerful antibiotics, are extremely destructive to the gut microbiome and gut microbiome health has also been linked to autism (17).

Even though a pretty good argument can be made for fluoroquinolones causing autism, if there is a relationship, it is not entirely clear-cut.  There are children who have been hurt by fluoroquinolones, but there are also children who have been administered fluoroquinolones without any apparent harm.  Like adults, children almost certainly have a tolerance threshold for fluoroquinolone use before they are injured.  Delayed adverse reactions (18) make recognition of symptoms of fluoroquinolone toxicity difficult to recognize, and recognition in the pediatric population is even more difficult because children have incompletely developed communication skills.  Studies that take into account delayed reactions and tolerance thresholds for fluoroquinolones have not been conducted on the adult population, much less the pediatric population, and thus it is unknown what the true effects of fluoroquinolones are.

It is possible that parental genes are altered by fluoroquinolone use and the damaged genes are passed on to children.  This possibility has not yet been explored, but, anecdotally, it does not appear to be a clear-cut relationship either.  Many mothers and fathers who have suffered from fluoroquinolone toxicity have had neurodevelopmentally normal children.  Some have had neurodevelopmentally challenged children though too, and it would be nice to see an actual study of the children of parents exposed to fluoroquinolones, as opposed to the anecdotes that are currently available.

Autism is a complicated disorder (or set of disorders) that likely has multiple environmental, genetic and epigenetic causes.  I strongly suspect that fluoroquinolones are part of the autism-cause-puzzle, but I also suspect that other cellular poisons compound the deleterious effects of fluoroquinolones on neural synapses, and can trigger autism.

Autism_Spectrum_Disorder-1

I noted above that adverse reactions to fluoroquinolones are often delayed.  Delayed adverse reactions to fluoroquinolones have been reportedly triggered by other stressors, including other pharmaceuticals (especially NSAIDs and steroids), benzodiazepine withdrawal, vigorous exercise, emotional stress, alcohol, hormonal changes and other things that can alter neurotransmitters and the autonomic nervous system.  The combined effects of fluoroquinolones and subsequent stressors have not yet been studied, despite (some) recognition of delayed adverse reactions to fluoroquinolones.

Given the indications of “Topoisomerases facilitate transcription of long genes linked to autism,” and “Topoisomerase 1 inhibition reversibly impairs synaptic function,” it is certainly prudent to explore whether or not fluoroquinolones affect gene expression similarly to topotecan.  Other drugs that inhibit topoisomerase activity, such as irinotecan and camptothecin, demonstrated similar effects to those of topotecan and thus the UNC researchers “speculate that other drugs that inhibit TOP1 or TOP2 enzymes could have similar effects on synaptic function.”  We shall see if their results show that fluoroquinolones affect the expression of long genes.  I’m betting that they will find that fluoroquinolones dramatically alter gene expression, especially after multiple uses and also especially when combined with NSAIDs.  Given the prevalence of both fluoroquinolone antibiotics and NSAIDs in our environment though, I hope that I am wrong.

It was never prudent for fluoroquinolones to be used as first-line antibiotics.  They are dangerous, DNA and RNA disrupting chemo drugs that should only be used in life-or-death situations, not as treatment for travelers’ diarrhea or sinus infections.  They’re topoisomerase interrupters.  They’re topoisomerase interrupters.  They’re topoisomerase interrupters.  They’re topoisomerase interrupters.  I’m not sure how many times I need to say that for people who know what topoisomerases are (those who went to medical school) to recognize that it is NOT APPROPRIATE TO GIVE TOPOISOMERASE INTERRUPTING DRUGS TO CHILDREN (or anyone else who isn’t dying).

A former biochemist friend noted, “I was stunned that people thought quinolones were perfectly safe. Coming through the ranks, I always thought, as was taught, that they were a last-ditch drug. There was absolutely no long-term research done with them, and apparently still isn’t.  But there sure was money involved.”

Long-term and intergenerational research need to be done on drugs that affect DNA before they are released into the public.  Neither long-term nor intergenerational studies were done on fluoroquinolones before flooding the market with them.  The odd intricacies of how fluoroquinolones affect people were not taken into consideration either—things like delayed effects, tolerance thresholds, drug and hormonal interactions, etc.

I’m hopeful that the UNC scientists that are looking at the interactions between topoisomerases and autism will start screaming about the deleterious effects of fluoroquinolones on our genes.  I hope that they have the resources to do the study with delayed adverse reactions and tolerance effects taken into consideration too.

We shall see.

I’m hopeful that the study will be well-done and, if not conclusive, interesting–and that it opens the door for more research.

I can’t say that I hope that fluoroquinolones are a unifying cause of autism spectrum disorders, because that would be too sad.

One thing that I’ve found through researching how fluoroquinolones damage human health, is an appreciation for how complex and multifaceted humans are.  Nothing happens in isolation.  There are feedback and feedforward loops within the body that compound the effects of a stimulus on one bodily system on another, there are interactions between drugs that can occur long after a drug “should” have cleared the body, the interactions between mitochondria and neurotransmitters and cellular signaling exist but little is known about them, and more.  It is difficult, if not impossible, for scientists to adequately take into account the incredible complexity of the human body.  What is not known cannot be taken into consideration, and don’t for a second think that we know “enough” about the human body to be throwing pharmaceuticals that are topoisomerase interrupters into the mix.

Fluoroquinolones never should have been approved for human use until long-term, intergenerational safety studies were performed.  They should be taken off of the market until those studies are done.  That won’t happen though.  Drugs aren’t taken off of the market unless they immediately kill a lot of people.  The damage that fluoroquinolones do is more nuanced than that.  If pharmaceutical makers can create a drug that is complex enough, and that can affect people in multiple different ways—through affecting gene expression—they can get away with just about anything.  Bayer and Johnson & Johnson have figured this out.  The FDA isn’t smart enough to protect the public.  Individuals need to be smart enough to protect themselves and their families—a difficult thing to do considering that some knowledge of biochemistry and genetics is necessary for protection against dangerous pharmaceuticals.

Fluoroquinolones are topoisomerase interrupters.  They’re topoisomerase interrupters.  They’re topoisomerase interrupters.  They’re topoisomerase interrupters.  They’re topoisomerase interrupters.  Repeat until someone who should know better shouts – “STOP.”

REMAINING QUESTIONS

The existing research into connections between topoisomerase interrupting drugs and autism spectrum disorders raises multiple questions.  It would be nice if some money, time, effort and other resources were devoted to answering these questions.

  1. What are the effects of fluoroquinolone antibiotics on nuclear, mitochondrial and microbiome gene expression?  What are the implications of these effects?
  2. Do topoisomerase interrupting drugs change gene expression of the person who takes them, the offspring of the person who takes them, or both?
  3. Do topoisomerase interrupting drugs increase a person’s chances of having a child with Autism? How?
  4. If a person takes a topoisomerase interrupting drug, is their DNA altered? If so, are the changes temporary or permanent?
  5. Are some people’s genes affected by these drugs more than others? What factors determine whether or not an individual’s genes are affected?
  6. Are DNA/gene alterations triggered by pharmaceuticals reversible? If so, how?
  7. What, if anything, can people who have taken these drugs do to discourage the expression of the ASD related genes?
  8. When would the administration of the drug happen to influence genes in a way that could trigger the genes associated with Autism – when a mother is pregnant or at any point before the child is conceived – or does the drug need to be directly administered to the person whose genes are altered?
  9. Do these drugs change gene expression in the ways that diet and music change gene expression or do they change DNA like Agent Orange? What level and scale are we talking about?

SOURCES:

  1. Ian F. King, et al. “Topoisomerases facilitate transcription of long genes linked to autismNature – author manuscript. 2013 Sep 5; 501(7465): 58–62.
  2. FDA Safety Announcement, “FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection” 08/15/2013
  3. Adam D. “Use of quinolones in pediatric patients.” Reviews of Infectious Diseases. 1989 Jul-Aug;11 Suppl 5:S1113-6.
  4. Ciprodex Warning Label
  5. CDC Newsroom Press Release, “CDC estimates 1 in 68 children has been identified with autism spectrum disorder” March 27, 2014
  6. FDA Warning Label for Cipro/Ciprofloxacin
  7. Mabb AM, et al. “Topoisomerase 1 inhibition reversibly impairs synaptic function.” Proceedings of the National Academy of Sciences of the United States of America, 2014 Dec 2;111(48):17290-5. doi: 10.1073/pnas.1413204111. Epub 2014 Nov 17.
  8. Antonei B. Csoka and Moshe Szyf. “Epigenetic side-effects of common pharmaceuticals: A potential new field in medicine and pharmacology.” Medical Hypotheses 73 (2009) 770–780
  9. JW Lawrence, et al. “Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells.” Molecular Pharmacology November 1996 vol. 50 no. 5 1178-1188
  10. Martin Pickard, et al. “Progressive increase in mtDNA 3243A>G heteroplasmy causes abrupt transcriptional reprogrammingProceedings of the National Academy of Sciences of the United States of America, 2014 Sep 23; 111(38): E4033–E4042.
  11. Pharmacology Weekly Newsletter, “What is the mechanism by which the fluoroquinolone antibiotics (e.g., ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin) can increase a patient’s risk for developing a seizure or worsen epilepsy?” August 31, 2009.
  12. Sameer Kalghatgi et al. “Bactericidal Antibiotics Induce Mitochondrial Dysfunction and Oxidative Damage in Mammalian Cells.” Science Translational Medicine, 5, 192ra85 (2013)
  13. Suzanne Goh, et al. “Mitochondrial Dysfunction as a Neurobiological Subtype of Autism Spectrum Disorder – Evidence From Brain ImagingJAMA Psychiatry. 2014;71(6):665-671
  14. Marta Kicia, et al. “Comparison of the effects of subinhibitory concentrations of ciprofloxacin and colistin on the morphology of cardiolipin domains in Escherichia coli membranes.” Journal of Medicinal Microbiology, April 2012 vol. 61 no. Pt 4 520-524
  15. G Palu, et al. “Quinolone binding to DNA is mediated by magnesium ionsProceedings of the National Academy of Sciences of the United States of America, Vol. 89, pp. 9671-9675, October 1992
  16. Richard E. Frye, MD, PhD, and Daniel A. Rossignol, MD, FAAFP, “Cerebral Folate Deficiency in Autism Spectrum Disorders” Autism Science Digest: The Journal of Autism One. Issue 02.
  17. Jennifer G. Mulle, et al. “The Gut Microbiome: A New Frontier in Autism Research.” Current Psychiatry Rep. 2013 Feb; 15(2): 337.
  18. Jacquelyn K. Francis, BA and Elizabeth Higgins, MD, “Permanent Peripheral Neuropathy: A Case Report on a Rare but Serious Debilitating Side-Effect of Fluoroquinolone AdministrationJournal of Investigative Medicine High Impact Case Reports 1–4 © 2014 American Federation for Medical Research
  19. Thomas D. Gootz, et al. “Inhibitory Effects of Quinolone Antibacterial Agents on Eucaryotic Topoisomerases and Related Test SystemsAntimicrobial Agents and Chemotherapy. Jan. 1990, P. 8-12.
  20. Mukherjee, S. Sen, K. Agarwal, “Ciprofloxacin: mammalian DNA topoisomerase type II poison in vivo.” Mutation Research Letters. Volume 301, Issue 2, February 1993, Pages 87–92

 

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The Floxie Hope Podcast Episode 11 – Diego

Diego Floxie Hope Podcast

I had the pleasure of interviewing Diego Vasquez for Episode 11 of The Floxie Hope Podcast.

Diego is thoughtful and wise.  His perspective on his floxing journey is poignant and beautiful.  I very much enjoyed speaking to Diego and he even brought me to tears during the interview.  I encourage all of you to listen to this podcast and share it with friends.  Diego has an amazing, uplifting, inspirational spirit.  You will be sure to be touched by this interview.

You can read about Diego’s Journey here – https://floxiehope.com/diegos-story-levaquin-side-effects/

You can listen to Diego’s Journey through these links –

https://itunes.apple.com/us/podcast/floxie-hope-podcast/id945226010

http://www.floxiehopepodcast.com/episode-011-diego/

Diego mentions that he is being treated for peripheral neuropathy by The San Antonio Neuropathy Center.  You can learn about the Center from this video –

 

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Why Hasn’t Levaquin Been Taken Off The Market?

In 1992 the fluoroquinolone antibiotic Omniflox/temifloxacin was removed from the US market after causing three deaths.

To note the removal from the market, the FDA released the following statement:

            “The Food and Drug Administration today announced that Abbott Laboratories of Abbott Park, Ill., is voluntarily recalling the broad-spectrum anti-infective drug Omniflox (temafloxacin) tablets, and will halt all further distribution of the drug.

            This action is being taken because of severe adverse events associated with the use of the drug that have been reported to the company and to FDA in the first three months of marketing.

            Temafloxacin was approved in late January 1992 and marketed in mid-February.  Since that time there have been approximately 50 reports of serious adverse reactions, including three deaths.  There were several cases of severe low blood sugar, especially in very elderly patients with decreased kidney function.  Among the severe reactions there were a number of cases of an unusual complex of adverse reactions consisting of hemolitic anemia (destruction of red blood cells) and other blood cell abnormalities.”

I’m glad that Omniflox/temafloxacin was removed from the market.  I’m glad that, in 1992, the FDA was able to move quickly to do the right thing and take a dangerous drug off the market.

It begs the question though – Why is Levaquin/levofloxacin still on the market? 

Levaquin/levofloxacin has caused far more than three deaths.  According to an FDA review with the subject, “Pediatric Exclusivity Postmarketing Adverse Event Review,” between 12/20/1996 and 08/27/2008, 924 people were killed by Levaquin/levofloxacin, including three children.

levofloxacin AERS Data

It should be noted that, “Many studies have documented that only 10%-15% of serious adverse reactions are reported” to the FDA.  Seeing as adverse reactions to Levaquin/levofloxacin, and other fluoroquinolone antibiotics, are often delayed and bizarre in their nature (who would think that multi-symptom, chronic illness could result from taking an antibiotic?), it is reasonable to think that only 10% of the reactions to  Levaquin/levofloxacin are reported to the FDA.

Assuming that only 10% of the harm was reported, 9,240 people (including 30 children) were killed by Levaquin/levofloxacin in the 12 years measured.

Additionally, there were 10,166 reports of harm done by Levaquin/levofloxacin in that time period.  If that’s 10% of the actual harm done, 101,660 people were harmed by Levaquin/levofloxacin in that 12 year period.

Again, THREE people died from Omniflox/temafloxacin before it was promptly pulled from the market in 1992.  Johnson & Johnson is apparently on friendlier terms with the FDA than Abbott Labs.

Rest in Peace Chris Dannelly

Since 2008, Levaquin/levofloxacin has claimed many more victims.  Chris Dannelly is one of the people who tragically died after taking levofloxacin in January, 2013.  Chris was a 41 year old husband and father of two young kids.  He was an athlete at the prime of his life.

Chris FQWall

Chris was killed by two pills of levofloxacin.  You can read Chris’s story HERE.  From Chris’s Story, “After reviewing the autopsy report, doctors stated that ‘all signs point to Levaquin’ as being the cause of death.” And, “Chris was a healthy, active man in the prime of his life. He worked out five days per week, and enjoyed playing both indoor and outdoor soccer regularly. Within a matter of less than a week’s time he went from being perfectly healthy, to losing his life…all because he took two little pills of Levaquin.”

Chris’s tragic story, highlighted by WSB-TV 2 out of Atlanta, Georgia, and told by Chris’s brave wife Kathy, can be viewed here –

Kathy states in the interview, “If I can get involved in this drug somehow coming off the market one day – then that’s the least I can do.”

Because Chris was given levofloxacin, the generic form of the drug, and the Supreme Court decided that drug manufacturers couldn’t be held responsible for harm caused by generic drugs, neither Kathy nor her children have the opportunity to pursue legal recourse for Chris’s tragic death.  Taking this horrible drug that killed her husband off the market is the least the FDA can do to right this tragic situation of a husband, father and athlete being killed by a dangerous drug like Levaquin/levofloxacin.

Rest in Peace Richard Davis

Also on  WSB-TV 2 Atlanta, Sandy Davis tells the story of how her husband Richard was killed by Levquin/levofloxacin:

Sandy Davis states, “I don’t think it should even be on the market.  If it’s killing people – No.”  Indeed.  Richard was 60 years old when he passed.

But, but, but…

People will argue that we need Levaquin/levofloxacin because bacterial resistance to antibiotics is making more powerful antibiotics necessary.  There may be some truth to that argument.  But rather than seeing dangerous, complex drugs like Levaquin/levofloxacin in simplistic black and white terms, perhaps some thoughtful consideration of the grey area is in order.

IF it is deemed impossible for the FDA to remove Levaquin/levofloxacin from the market (and I do believe that it should be taken off the market – it is, after all, KILLING PEOPLE), it should be severely restricted.  Levaquin/levofloxacin should ONLY be used in life or death situations.  It should ONLY be used when all other non-fluoroquinolone antibiotic options have been exhausted.  It should ONLY be used in patients who haven’t previously been exposed to fluoroquinolones.  It should ONLY be used in people who are not genetically predisposed toward an adverse reaction to fluoroquinolones.  (Who is genetically predisposed toward an adverse reaction to Levaquin/levofloxacin?  Good question.  Figure it out, FDA.)  It should NEVER be given to children, athletes, the elderly, those with an autoimmune disease, those with autonomic nervous system dysfunction, those with a history of psychiatric illness, or anyone who needs to use contraindicated drugs, like steroids and NSAIDs, to survive.

IF Levaquin/levofloxacin must stay on the market, everyone who takes it should be provided with information that ensures that they know that Levaquin/levofloxacin can cripple or kill them.

Before anyone insists that Levaquin/levofloxacin must stay on the market, perhaps we (collectively) should do some due diligence to make sure that it, and other fluoroquinolone antibiotics, don’t have intergenerational adverse effects.  After all, their mechanism of action is interruption of topoisomerase enzymes, enzymes that are necessary for DNA and RNA replication.  In case it needs to be said, disrupting the DNA and RNA replication process of cells may have some deleterious effects on future generations.  Don’t assume for a second that this concern has been examined.  Warnings about the DNA toxicity of fluoroquinolone antibiotics have been ignored.

fluoroquinolone-lawsuit-banner-trulaw

Though I understand that antibiotic resistance and loss of antibiotic efficacy is a problem, I can’t say that I entirely buy arguments that Levaquin/levofloxacin must stay on the market.  No one claims that we are worse off because Omniflox/temafloxacin was removed from the market.  Infections were also being adequately treated by non-fluoroquinolone antibiotics prior to 1987, when Levaquin/levofloxacin was approved by the FDA.

Kathy Dannelly and her children, Sandy Davis and her loved ones, and all other loved ones of victims of Levaquin/levofloxacin deserve justice.  Many of them aren’t getting justice.  The least that the FDA can do is keep others from dying in pain from fluoroquinolone toxicity caused by Levaquin/levofloxacin.

 

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Media Coverage of Fluoroquinolone Antibiotic Dangers

WSB-TV 2 out of Atlanta, Georgia has run several news segments about the dangers of fluoroquinolone antibiotics – focusing on the death and destruction caused by Levaquin/levofloxacin.

A HUGE THANK YOU TO EVERYONE INVOLVED IN MAKING THIS POSSIBLE!  WSB-TV 2 producers and other staff, Jim Strickland, Kathy Dannelly, Donna Schultz, Jeff Stephens, Lynne Whitcopf, Dr. Keith Jeffords, Sandy Davis and everyone else who spoke up about the dangers of these drugs – THANK YOU!

Here are the video clips from WSB-TV 2 –

You can read the story here – http://www.wsbtv.com/news/news/local/local-woman-says-popular-antibiotic-killed-her-hus/njzwj/

Per The Quinolone Vigilance Foundation‘s facebook page, “QVF has just been informed moments ago by ABC2 WSB-TV that the number of shares from the news stories have increased from 2 million to 3.9 million.”  WOW!  Great job getting the word out!

Here is another story featuring Lynne Whitcopf and Dr. Keith Jeffords, and their stories of pain –

http://www.wsbtv.com/news/news/local/patients-suffer-devastating-side-effects-popular-a/nj4Br/

When a doctor reports that, “It was an amazing amount of pain, to the point that I couldn’t walk,” and has to crawl out of the hospital to avoid more fluoroquinolones, you KNOW that the situation is bad.

Sandy Davis sadly lost her husband Richard to levofloxacin.  Here is her story –

http://www.wsbtv.com/news/news/local/woman-says-popular-antibiotic-levofloxacin-killed-/nj5jY/

I’m so sorry for the pain that was experienced by all those who were interviewed.  I appreciate that each of you told your story of pain!  These stories are important!

 

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Fluoroquinolones and Dental Problems

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This post, “Can Fluoroquinolone Antibiotics Cause Dental Problems?” published on Hormones Matter, is not very hopeful.  In fact, it’s quite frightening.  Many patient reports have been coming in lately about fluoroquinolone induced dental problems and teeth falling out.  Christopher’s story, on The Fluoroquinolone Wall of Pain is one of the stories highlighted.  Having all of your teeth fall out is a hefty price to pay for using an antibiotic – especially an antibiotic that is regularly prescribed for urinary tract and sinus infections.

I couldn’t find much in the way of journal articles about fluoroquinolone toxicity and dental problems.  If any of you find journal articles with dental problems listed as an effect of fluoroquinolones, please let me know.

The patient reports are quite compelling though – and frightening.

A couple people have mentioned that magnesium supplementation helps their post-flox teeth.  It’s probably a good thing to keep up.

On a personal note, I love my teeth.  Vanity is certainly at play, but I have really good teeth and I’d like to keep them.  I lost a tooth to internal resorbtion – basically, the root disintegrated for no reason – a long time before I took a FQ.  That stunk, for sure.  I can only imagine the horror of losing all of one’s teeth.  Hugs to those who are having post-FQ dental problems!

 

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FDA Petitioned to Add Psychiatric Side Effects to Black Box Warning for Fluoroquinolones

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In a survey of 94 people who experienced adverse reactions to Levaquin/levofloxacin, a fluoroquinolone antibiotic, 72% reported experiencing anxiety, 62% reported depression, 48% reported insomnia, 37% reported panic attacks, 33% reported brain fog and/or cognitive impairment, 29% reported depersonalization and/or derealization, 24% reported thoughts of suicide and 22% reported psychosis.

Psychiatric side-effects of fluoroquinolones are common.  Though many of the psychiatric adverse effects of fluoroquinolones are listed on the warning label, they are buried in the “Central Nervous System Effects” section.  Dr. Charles Bennett of the Southern Network on Adverse Reactions (SONAR), has submitted a petition to the FDA requesting that a black box warning about serious psychiatric adverse events be added to the Levaquin/levofloxacin warning label.

More information about the serious psychiatric adverse effects of fluoroquinolones can be found in this post –

PSYCHIATRIC SIDE EFFECTS OF FLUOROQUINOLONE ANTIBIOTICS

Please spread the word about the psychiatric problems that fluoroquinolones can cause.  The serious psychiatric adverse effects of fluoroquinolones are under-recognized.

People are suffering because they are not adequately warned about the dangers of fluoroquinolones.

Thank you for reading and sharing the post!

 

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