Tag Archives: antibiotics

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

 

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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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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Dr. Perlmutter Speaks About the Microbiome and Advocacy

Yesterday I went to a wonderful event at a Natural Grocers where Dr. David Perlmutter spoke about the importance of nourishing your microbiome with healthy foods.

According to his amazon.com bio, “David Perlmutter, MD, is a globally recognized leader in brain science. He is the recipient of the Linus Pauling Award, editor-in-chief of the global online and print peer-reviewed journal Brain and Gut, and author of the #1 New York Times bestseller Grain Brain, The Grain Brain Cookbook, Brain Maker, The Better Brain Book, Raise a Smarter Child by Kindergarten, and Power Up Your Brain. He lives and practices in Naples, Florida.”

Dr. Perlmutter understands the connections between microbiome health and brain health. He speaks out about the connections between microbiome destruction via over-use of antibiotics, and chronic illness. He has acknowledged fluoroquinolone toxicity on news-casts, and has made videos about fluoroquinolone-induced peripheral neuropathy.

His presentation was wonderful and if you get the opportunity to see him speak, I recommend that you do so.

I had the opportunity to thank Dr. Perlmutter for the work he’s done speaking out about fluoroquinolone toxicity.

I also had the opportunity to ask him, in the Q&A section in front of the whole audience, what can be done to encourage more doctors to understand that fluoroquinolone antibiotics are dangerous drugs that should not be used frivolously. He responded that speaking out was the way to bring about change, and that doctors and other people can be educated about the dangers of fluoroquinolones one person at a time.

Every time we share an article that connects microbiome destruction to chronic illness (several are linked to HERE), we encourage people to understand that microbiome health is critical for all areas of health, and that throwing a nuclear bomb into the gut with fluoroquinolones (information about the dangers of fluoroquinolones can be found HERE), can be devastating.

Dr. Perlmutter also spoke about how mitochondria are ancient bacteria, and every time we share information about how fluoroquinolones damage mitochondria, we are also increasing the chances of doctors and other people making the connections between mitochondria-damaging drugs and chronic illness.

The outreach advice I got from Dr. Perlmutter and Dr. Wahls (in Episode 14 of The Floxie Hope Podcast) was to keep screaming, keep telling people about fluoroquinolone toxicity, and one person at a time, minds will change.

For fluoroquinolone toxicity to be on the radar of someone as influential as Dr. Perlmutter is a HUGE step in the right direction for us. He reaches millions of people through his books, web site, journal, practice, and other contributions. If you get a chance to thank him for his fluoroquinolone toxicity awareness efforts, please do so. He is brilliant, thoughtful, interesting and a wonderful advocate. He has my respect and admiration.

 

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But Antibiotics Save Lives!!!

David Wolfe, a health, eco, nutrition and natural beauty expert (more information about him can be found HERE) posted the picture above on facebook.  He has more than 1,200,000 facebook followers and I greatly appreciate his help in spreading the word about the dangers of fluoroquinolones!  Many people commented on picture and told their story of how fluoroquinolones hurt them.  There are a lot of us out there, and the more the word gets spread, the more likely change is.

As always, there were some nay-sayers.  Honestly, there were a lot more people sharing their stories than there were nay-sayers, and I’m not suggesting that we all gang up on them, but I have some thoughts about the some of the nay-saying comments.  Here are some examples of the nay-saying comments:

“Want to go back to the dark ages before antibiotics?”

“If we didn’t have antibiotics…alot of people would die..”

“People who don’t believe in medicine should live on their own island of ignorance and watch their life expectancy drop to that of their intelligence.”

“Without antibiotics you can’t treat people with bacterial infections. Aka ur screwed. Pls don’t mislead the public. stick to quotes. My sincere request. Please.”

“Antibiotics have saved over 1 billion lives. Mr Wolfe’s irresponsible comments will cause deaths!!”

“WAIT! Are you trying to scare people off antibiotics now??? How many people would have to die of preventable illnesses before you retract this?”

Sigh.  Why do these people think that all antibiotics are the same?  Why do they think that all antibiotics are safe?  Why do they think that warning people about the dangers of fluoroquinolones equates to being anti-antibiotic?  Where is the grey area?  Can’t some antibiotics be appropriate for use in some circumstances but not others?  Can’t different antibiotics have different safety profiles?  Isn’t information about the dangers of drugs valuable so that people can make informed choices?  Doesn’t it matter that fluoroquinolones damage nerves, the musculoskeletal system, the eyes and kidneys?  Can’t that information lead to greater consumer knowledge and informed consent when fluoroquinolones are prescribed?  Can’t the dangers of fluoroquinolones be acknowledged without being “anti-antibiotic?”  Can’t we fight for prudent and appropriate use of all antibiotics (especially FQs) without negating the lives that have been saved by antibiotics (including FQs)?  GREY AREA, folks!  The world isn’t black and white.  Sigh.

A quote from my most recent post, “‘The 21st Century Cures Act’ Is On Its Way – Here’s Why You Haven’t Heard About It” seemed like an appropriate response to a lot of the nay-sayers.  Feel free to use this if you want it:

“A healthy and balanced microbiome (“the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space”) is crucial for all areas of health, and a disturbed microbiome has been linked to all of the diseases of modernity, including mental health disorders, neurodegenerative diseases like Parkinson’s and Alzheimer’s, autoimmune diseases, inflammatory bowel disease and Crohn’s disease, mysterious diseases like fibromyalgia, autism, etc. And while there is acknowledgement of the role that a healthy microbiome plays in these diseases, researchers and journalists alike have been loath to acknowledge the role antibiotics have played in contributing to these diseases of modernity. No one wants to be anti-antibiotic. Everyone knows that antibiotics have saved millions of lives, but that doesn’t mean they are without consequences. And the good that penicillin has done doesn’t mean that all antibiotics are equally safe or effective. I can make a pretty thorough argument that fluoroquinolone antibiotics, like Cipro/ciprofloxacin and Levaquin/levofloxacin, drugs that work by “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,” are at least partially responsible for many of the diseases of modernity (more information can be found HERE, HERE and HERE). Fluoroquinolone antibiotics do not have the same safety profile as amoxicillin, and to assume that they do because both are categorized as antibiotics, is foolish on multiple levels.”

That’s my two cents of a response to the people who say things like the quotes above.  Also, quit giving carte blanche to the pharmaceutical companies if they label their dangerous drug as an antibiotic, because that’s just stupid.

Now I’m done.  🙂

 

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“The 21st Century Cures Act” Is On Its Way – Here’s Why You Haven’t Heard About It

The 21st Century Cures Act promises to make a lot more floxies. If a drug is an antibiotic, phase 3 testing won’t be required; all antibiotics will be rushed to market and hospitals will be rewarded for using the experimental drugs. New fluoroquinolones will surely be made and old ones are likely to be put back on the market. Warn everyone. This is NOT good.

Please read the post on Collective Evolution:

“The 21st Century Cures Act” Is On Its Way – Here’s Why You Haven’t Heard About It

 

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Letter to Congress Re the 21st Century Cures Act

The 21st Century Cures Act is going through the Energy & Commerce Committee now. You can read more about the Act here – http://energycommerce.house.gov/cures. The 21st Century Cures Act is a thinly veiled corporate give-away for the pharmaceutical companies. There are many things that I object to in the Act, but I think that its momentum is unstoppable so I’m recommending changes to it, rather than killing it. I am going to send the following letter to the bill’s sponsors, Fred Upton and Diana DeGette. I will also send this letter to my Congressional representatives. I encourage everyone reading this to send a letter to Congressman Upton, Congresswoman DeGette and other Congressional representatives. Please feel free to use my letter as a template, or to customize it as you see fit.

Also, please “tweet” your letters, stories, and anything else that you want to say about the 21st Century Cures Act to the Energy & Commerce Committee @HouseCommerce, Representative Upton @RepFredUpton, Representative DeGette @RepDianaDeGette and use the hashtags #Cures2015 and #Path2Cures. Thanks!

May 16, 2015

Re: Inclusion of Consumer Protection against Adverse Drug Reactions in the 21st Century Cures Act

Dear Chairman Upton and Representative DeGette:

I am writing because I have suffered from an adverse reaction to a popular pharmaceutical, and I would like to see more consumer protection and safety measures added to the 21st Century Cures Act.

At the age of 32, I went from doing crossfit regularly to barely being able to walk because I suffered from an adverse reaction to ciprofloxacin, a powerful fluoroquinolone antibiotic that can permanently damage all the nerves and connective tissues in one’s body. In addition to loss of mobility, I suffered from memory loss, loss of reading comprehension, loss of energy, and pain. There are many people who have significantly worse reactions than I did.

Because adverse reactions to fluoroquinolone antibiotics (and other pharmaceuticals) can be delayed, they are bizarre in nature (who would think that a prescription antibiotic could cause multi-symptom, chronic illness that resembles an autoimmune disease?), and adverse reactions can occur after previously tolerating the drug well, they are thought to be “rare.” I would argue that they are actually under-recognized.

However, since The 21st Century Cures Act focuses on “rare” conditions, I encourage you to focus some attention in the bill to “rare” adverse reactions to prescription drugs.

When people are hurt by a prescription drug they are often unable to gain help from the medical establishment (doctors can’t put your cells back together – the tv ads are misleading), and they are often unable to gain justice through the legal system (if a devastating adverse effect is listed on the warning label, you cannot sue because “you were warned”).

The pharmaceutical companies need to take more responsibility for the damage that the drugs that they create and manufacture do. Warning labels are not enough. They simply shift the blame from the maker of the drug to the victim of the drug. Enclosed is a plan to make pharmaceutical companies take responsibility for the harm done by the drugs that they discover, produce and put into the market.

The 21st Century Cures Act is proposing to get rid of many safeguards that are currently in place that keep dangerous drugs from entering the market. This is the wrong thing to do. More consumer safeguards need to be put in place, not fewer. If you are going to get rid of phase III clinical trials for potentially dangerous drugs, there MUST be systems in place to gather information about adverse reactions that occur in the general public that is consuming the drugs. I encourage you to put systems in place that require long-term and intergenerational studies to be performed on all drugs that are on the market.

The 21st Century Cures Act has a section that focuses on encouraging the development of new antibiotics. While it should be acknowledged that antibiotic resistance is a problem, the solution should be focused on prudent use of antibiotics, not the development of stronger antibiotics. Antibiotic drugs are not benign. I was hurt by an antibiotic drug—ciprofloxacin. It caused a multi-symptom syndrome that looked and felt like an autoimmune disease. Fluoroquinolone antibiotics have been found to have deleterious effects on mitochondria, neurotransmitters, the microbiome, the endocrine system, and more. Long-term studies to see if they are causally related to the many chronic diseases of modernity that are affected by mitochondria, neurotransmitter, microbiome and hormonal health, have not been conducted. Long-term studies on dangerous drugs like fluoroquinolones, that work by disrupting the DNA and RNA replication process for bacteria and mitochondria, should be conducted before the production of more drugs in their class is encouraged.

More attention should be paid to causes of the chronic diseases that plague our society. A major cause of chronic disease is ongoing cellular damage caused by pharmaceuticals.

Please balance out the 21st Century Cures Initiative so that it takes into consideration that pharmaceuticals are inherently dangerous and have multiple, often unacceptable, adverse effects. Moves toward greater drug safety are necessary and appropriate.

Thank you,

Lisa Bloomquist

Lakewood, Colorado

Enclosed: “A Public Policy Plan to utilize the Pharmaceutical Industry and Pharmacogenomics to reduce serious Adverse Drug Reactions, develop Personalized and Individualized Therapy, and provide a Functional Map of the Human Genome” by JMR on http://fluoroquinolonethyroid.com/

 

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The Microbiome According to Michael Pollan

Cooked by Michael Pollan Microbiome

I recently read “Cooked: A Natural History of Transformation” by Michael Pollan.  You can buy it HERE and a portion of the proceeds will go to the QVF.  I recommend that you purchase it, not just because some money will go to the QVF, but because it is beautifully written, enjoyable, interesting, insightful and poignant.

On the surface, Cooked has very little, if anything, to do with fluoroquinolone antibiotic toxicity.  Cooked is about the transformation of raw ingredients into food when fire, water, air and earth are applied to those ingredients through the process we call cooking.  The section of Cooked that has to do with how things from the earth–bacteria, fungi, etc., are used to transform and “cook” food, is the section I am going to connect to fluoroquinolone antibiotic toxicity.

Fluoroquinolone antibiotics are like a nuclear bomb to the gut.  They obliterate the microbiome, killing both good and bad bacteria in the gut and throughout the body.  They lead to a massive amount of oxidative stress within the gut that further damages the balance of bacteria in the gut.  It is only because of lack of knowledge about the importance of the microbiome that Cipro/ciprofloxacin only has a 43 page warning label, not a 100 page warning label.  In Cooked, Michael Pollan goes over the importance of the microbiome.  He explains the microbiome better than I possibly could, so I’m going to highlight some of my favorite quotes from Cooked in this post.

“Could it be possible that the microbiota also affects mental function and mood, as some of the fermentos I met in Freesone claimed?  The idea no longer seems preposterous.  A recent study performed in Ireland found that introducing a certain probiotic species found in some fermented foods (Lactobacillus rhamnosus JB-1) to the diet of mice had a measureable effect on their stress levels and mood, altering the levels of certain neurotransmitters in the brain.  Precisely how the presence of a certain bacterium in the gut might affect mental function is unclear, yet the researchers found they could block the effect by severing the vagus nerve that links the gut to the brain.  Studies like this one make you wonder if it might someday be possible to cultivate, or garden, our microbiota, altering its makeup to improve our physical and possibly also our mental well-being.

Right now, of course, and for the last several decades at least, we have been assiduously doing exactly the opposite:  disordering the community of microbes in our bodies without even realizing it, much less  with any sense of what might be at stake.  Under the pressures of broad-spectrum antibiotics, a Pasteurian regime of ‘good sanitation,’ and a modern diet notably hostile to bacteria, the human microbiota has probably changed more in the last hundred years than in the previous ten thousand, when the shift to agriculture altered our diet and lifestyle.  We are only just beginning to recognize the implications of these changes for our health.”

A book that is on my reading list (but that I haven’t yet read) is “Missing Microbes: How the Overuse of Antibiotics Is Fueling Our Modern Plagues” by Martin J. Blaser.  It’s supposed to be excellent.  It is about the diminishing diversity of our microbiota.

Back to Cooked:

“The average child in the developed world has also received between ten and twenty courses of antibiotics before his or her eighteenth birthday, an assault on the microflora the implications of which researchers are just beginning to reckon.  Like the pesticides applied to a farm field, antibiotics ‘work,’ at least in the short term.  Yet as soon as you widen the lens from a narrow focus on the ‘enemy species,’ you see that such blunt weapons inflict collateral damage to the larger environment, including, in the case of pesticides, the microbial community of the soil.  Resistant bugs and various other health problems soon emerge; the soil’s ability to nourish plants and help them withstand disease is also compromised, because the toxins have reduced the community’s biodiversity and thereby compromised its resilience.  As in the soil, so in the gut.  The drive for control and order ends up leading to more disorder.”

“An interesting question is why the body would enlist bacteria in all these critical functions, rather than evolve its own systems to do this work.  One theory is that, because microbes can evolve so much more rapidly than the ‘higher animals,’ they can respond with much greater speed and agility to changes in the environment–to threats as well as opportunities.  Exquisitely reactive and fungible, bacteria can swap genes and pieces of DNA among themselves, picking them up and dropping them almost as if they were tools.  This capability is especially handy when a new toxin or food source appears in the environment.  The microbiota can swiftly find precisely the right gene needed to fight it–or eat it.”

“Taken together, the microflora may function as a kind of sensory organ, bringing the body the latest information from the environment, as well as the new tools needed to deal with it.  ‘The bacteria in your gut are continually reading the environment and responding,’ says Joel Kimmons, a nutrition scientist and epidemiologist at the Centers for Disease Control and Prevention in Atlanta.  ‘They’re a molecular mirror of the changing world.  And because they can evolve so quickly, they help our bodies respond to changes in our environment.”

Bacteria gene-swap at the drop of a hat.  Isn’t that fascinating?  It also makes the fact that fluoroquinolones disrupt the process of bacterial DNA and RNA replication quite consequential.  I wrote this post about antibiotics altering bacterial DNA back in 2013 – http://www.collective-evolution.com/2013/10/23/genetically-modifying-humans-via-antibiotics-something-you-need-to-know/.  The consequences of altering bacterial DNA are still being explored.

Another book of Michael Pollan’s, “The Omnivore’s Dilemma: A Natural History of Four Meals” goes over the hazards of applying the industrial model to biological systems–specifically, the folly of using the industrial model to produce food when food production should be a biological, not an industrial, process.  The same is true for medicine.  The medical system treats people as machines with inputs and outputs and predictable outcomes based on those measured inputs and outputs.  It doesn’t work though.  Humans are biological systems with feedback and feedforward loops, genetic differences and epigenetic differences, nature and nurture differences, and more–that make conceptualizing humans as machines with predictable outcomes foolish and wrong-headed.  When land and animals are used to make food in an industrial, rather than biological, model, unsustainability, externalities and consequences result.  When biological systems are respected for the complex systems that they are, sustainability comes naturally.  Likewise, when human complexity is ignored and stupid, foolish, one-size-fits-all, industrial medicine prevails, consequences occur in place of health.  It turns out that consequences look a whole lot like chronic illness.  Whoops.

Lisa’s one-sentence summary of Cooked and The Omnivore’s Dilemma is – Don’t eat processed food.  Read the books for a more thorough explanation.  They’re both excellent.

 

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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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Lyme Disease and Fluoroquinolone Antibiotics

To my dear friends with chronic Lyme Disease,

I am so sorry for all that you are going through!  The pain, the exhaustion, the fear, the frustration – all of it.  My heart goes out to all of you!

I know that treatment options are a touchy topic, and that antibiotics are often a necessary part of dealing with Lyme Disease.  However, I’m going to jump right into a volatile sea and say, PLEASE, please, please be careful with antibiotics, and know that they are not all created equally.  Fluoroquinolone antibiotics – Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin – are chemo drugs that can do absurd amounts of harm.  I would hate for you to have to deal with two chronic illnesses at once – chronic Lyme and Fluoroquinolone Toxicity Syndrome.  Both are horrible.

Words of Wisdom from a Floxie with Lyme

A few comments on this site, from people who are dealing with both chronic Lyme Disease and Fluoroquinolone Toxicity, are more illustrative than anything I can say.  Here is a comment from my dear friend Catherine, who has been dealing with Lyme Disease for 18 years and Fluoroquinolone Toxicity for 2 years:

My situation is complicated, because I have been wheelchair bound with lyme and co infections for 18 years. I have had about 400 doses of Cipro and 12 days of avelox. I actually got quite a lot better on the cipro for about 4 years, before deteriorating again. Unfortunately, I didn’t realize it was the cipro – because I had done well on it before, it never occurred to me that it was now harming me – and carried on taking it for a year or two after I was first floxed. I then took nearly two weeks of avelox which finished me off, and I have now been bedbound for the last 18 months. I only made the connection between FQs and my health 12 months ago, when I took my last avelox.

I have had massive CNS and PN symptoms.  Over 100 symptoms in all. Some digestive issues too. By Christmas last year I felt that I had stabilized, but have recently developed new symptoms of dry eyes and receding gums.

Other aspects have improved – anxiety and panic attacks have lessened somewhat, and most nights I get 6 or 7 hours solid sleep.

Obviously, I’ve got a lot of damage to repair, and a long road ahead. This summer I have managed a few trips out in the car, which is more than I could do last summer. I have two young children, so I have to keep going for them!

She added, in a different comment on another conversation:

I had chronic borrelia and rickettsia for years before I began antibiotics. I then took FQs for years, and did well for a while. But at some point (I can’t be sure exactly when) I stopped doing so well and felt I was no longer responding – not just to FQs but to all the other antibiotics I was taking. And so the doctor gave me different and stronger FQs until eventually I became totally incapacitated and finally made the connection between FQs and floxing etc. I still don’t understand why the rickettsia/lyme now seems untouchable by any antibiotic. I would have thought after nearly 10 years of FQs I would have no infection left, but it’s worse and more virulent than ever. I can only guess that the FQs have effected a change in the rickettsia bugs themselves.

Tolerance Thresholds for Fluoroquinolones

Many people have suggested that fluoroquinolones bring out latent Lyme Disease.  I don’t know if this theory is true or not, as there haven’t been any studies (that I know of) trying to prove that hypothesis.

What has been shown to be true, however, is that fluoroquinolone antibiotics severely damage cells.  The parts of cells that are most damaged by fluoroquinolones are the mitochondria.  Mitochondrial damage is tricky in that both delayed adverse reactions, and tolerance thresholds are features of drug induced mitochondrial damage.  Thus, as Catherine’s comments illustrate, a drug that was once well tolerated can harm you the next time you have it.  (More info about tolerance thresholds for mitochondria damaging drugs can be found here – http://www.hormonesmatter.com/fluoroquinolone-time-bomb-mitochondria-damage/.)

Everyone’s tolerance threshold for fluoroquinolones is different.  Some people develop Fluoroquinolone Toxicity Syndrome after taking one pill.  Other people can handle hundreds of pills before their lifetime threshold is reached.  After an individual’s threshold is crossed though – the multi-symptom, chronic illness of Fluoroquinolone Toxicity results.

Delayed adverse reactions make it so that, often, people don’t even realize that they’ve crossed their tolerance threshold for fluoroquinolones until they have taken too many pills and the bomb in their body has gone off.  It’s Russian Roulette – but you can pull the trigger and release more and more bullets after the one that starts the reaction goes off – and each additional bullet does additional damage.

The symptoms of Fluoroquinolone Toxicity Syndrome are very similar to the symptoms of chronic Lyme Disease – pain, fatigue (um… bedridden exhaustion is more apt), insomnia, aching joints and muscles, decreased cognitive abilities, anxiety, depression and other psychiatric problems, etc.  The similarities between the two make it difficult to distinguish one from another.  They’re both real and they’re not mutually exclusive.  Some people even surmise that they’re related (but, like I mentioned above, I’m not sure about that).

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We’re in This Together

Humans like to break things into categories.  It helps us to understand them.  But, rather than attempting to convince you that your symptoms are from FQ toxicity, or listening to arguments that I might have latent Lyme, may I suggest that we all listen to Rene’s words of wisdom (also from a comment on www.floxiehope.com – Rene has also dealt with both Lyme and fluoroquinolone toxicity) :

Be careful about getting married to the disease label: “Look at the systems involved.” The massive amounts of data that I have combed through, during the years of illness, (before I was retested & given the diagnosis of Lyme), unveiled the commonality of all these illness or chronic conditions. If you have Lyme, MS, Fibromyalgia, Chemical Sensitives, Flouroquinolone injuries, Cancer it is a cellular issue of detoxification and efficiently utilizing the bio nutrients, the raw material we are made up of that send those signals & then receive the messages. The terrain is everything, which is why everything we eat and absorb is signally the terrain. The beliefs we have, what we covet and worship. How to improve the terrain and the function of these systems. Send the right signals and receive the right signals.

She also wrote:

the most beneficial & healing things you can do for Lyme are tantamount to doing much of what Fluoroquinolone injured do.

I know that for FQ toxicity, there is no one single “magic bullet” cure, but that many different things help people.  Some people are helped by a clean and healthy diet full of vitamins and minerals (Douglas recovered with the help of a healthy diet), some are helped by glutathione injections and liver cleanses (Richard was), Some are helped by antioxidant and mineral supplements (Ruth has some excellent antioxidant supplement advice), some are helped by alternative medicine (my acupuncturist helped me a lot) and most are helped by a combination of approaches.  All of the approaches are holistic and affect multiple systems.  Multiple systems with multiple negative feedback loops are broken by fluoroquinolones, and by Lyme spirochetes.  Systems break down with both diseases – and those broken systems break other systems.  The negative feedback loops are complex and difficult to fix.  But I thoroughly believe that the innate positive feedback loops are stronger than the negative feedback loops.  I hope that this belief is true.

All of us “spoonies” with under-recognized, systemic, often chronic illnesses have more in common than we don’t.  I hope that the stories of hope and healing on this page resonate with anyone with Lyme or any other chronic disease who reads this.

Back to Lyme and Fluoroquinolones

Perhaps I’m biased because fluoroquinolones hurt me, but I can’t believe that a drug that depletes mitochondrial DNA, leads to a massive amount of oxidative stress, depletes intracellular magnesium and decimates the microbiome is helpful to people who are already suffering from a chronic illness.  I understand that the Lyme bacteria need to be fought, but destroying your cells seems like a lousy way to do it.  (Interestingly, it has been suggested that tetracyclines, including doxycycline, are supportive of mitochondria whereas FQs are destructive.)  You need healthy cells in order to fight.  How to improve the health of your cells is a really difficult question and I don’t know the right answer.  I’m pretty sure that fluoroquinolones aren’t the answer to much though – certainly not for chronic Lyme Disease.

The main thing that I can ask of my friends with Lyme is this – please be careful.  Don’t think that the side-effects of drugs are “rare” or that they won’t happen to you.  Know the potential for chronic multi-symptom illness that comes with each fluoroquinolone pill, and if you choose to take Cipro, Levaquin or Avelox, do so with your eyes wide open.  Informed consent is, after all, quite important.

May you all find healing.

Best regards,

Lisa

 

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Antibiotics After Fluoroquinolone Toxicity

People often ask about what they should do to treat infections post-flox.  Here are my tips.

First, please INSIST on getting your infection cultured and confirmed before you take any antibiotics.  As anyone who has had an adverse reaction to an antibiotic can tell you, antibiotics are not benign drugs.  They have side-effects (HERE is the 43 PAGE warning label for Cipro/Ciprofloxacin).  Some of those side-effects are life-altering and/or life-threatening.  You don’t want to put any drugs into your body unless you absolutely need them.  A culture should be done to confirm that an infection is present before you take an antibiotic – no matter what.

Because antibiotics have been shown to wreak havoc on the microbiome and bactericidal antibiotics damage mitochondria – and because both microbiome disruptions and mitochondrial dysfunctions are linked with every chronic disease there is – I highly recommend looking into some non-pharmaceutical options first.  Garlic has been shown to have antibiotic qualities and to be more effective against biofilms than many antibiotics.  For urinary tract infections, D-mannose has effectively helped thousands of people get rid of their infection.  Some other non-pharmaceutical remedies for urinary tract infections can be found HERECoconut oil has been shown to have anti-bacterial qualities and it may be good for treating skin and GI infections.  Colloidal silver not only has anti-bacterial qualities on its own, it also has been shown to increase the effectiveness of pharmaceutical antibiotics when used in conjunction with them.  Andrographis is an herb that has antibiotic qualities.

If non-pharmaceutical options aren’t working and you need an antibiotic to get rid of your confirmed infection, here are the antibiotics that I recommend along with reasons as to why I recommend them (or not).

  1. Most Floxies seem to do well with doxycycline and other tetracyclines. Tetracyclines are bacteriostatic antibiotics that, “stops bacteria from multiplying but does not kill them.” (source)
  2. Several Floxies have taken Z-pack’s without incident
  3. Amoxicillin seems to be about as benign as antibiotics get. So, it’s not harmless, but it’s well tolerated generally.
  4. Penicillin seems to be well tolerated – unless you’re allergic to it.
  5. Cephalosporins seem to be well tolerated

There are probably some other antibiotics that are fine for Floxies, I just haven’t heard about them.  Please feel free to leave a comment below if there is an effective and relatively safe one that I’m missing.

Here are the antibiotics that I recommend avoiding because they have side-effects that are similar to those of fluoroquinolones, and because many Floxies react badly to them –

  1. Macrobid / Nitrofurantoin
  2. Flagyl / Metronidazole
  3. Bactrim / Trimethoprim / Sulfamethoxazole
  4. Augmentin

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Fluoroquinolones – Cipro/Ciprofloxacin, Levaquin/Levofloxacin, Avelox/Moxifloxacin, Floxin/Ofloxacin and a few others – should be avoided entirely unless you are dying and make the decision that getting “floxed” is preferred to death.  Every warning label for every fluoroquinolone says that people who have an existing hypersensitivity to a fluoroquinolone should not take them again.  “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.” (Warning Label)

Before you take an antibiotic, or any pharmaceutical for that matter, I highly recommend that you look up the review for that drug on http://www.askapatient.com/ and look it up on http://www.peoplespharmacy.com/.  Also, look up the drug’s warning label.  Be informed.  Make an informed decision.

Here is a list of antibiotics – http://en.wikipedia.org/wiki/List_of_antibiotics  I didn’t get close to going through all of them.  But I hope that this post gives you some guidance when/if you are faced with an infection.

I’m not a doctor, so please take this advice for what it’s worth.  Doctors should be consulted when you have an infection.  The internet should be consulted too though, because doctors aren’t capable of knowing everything and informed consent is really important.

 

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Fluoroquinolone Antibiotics Damage Mitochondria – FDA Does Little

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The Pharmacovigilance folks at the FDA know that fluoroquinolones are damaging mitochondria.  Yet, they look the other way.  Adding a more severe warning about peripheral neuropathy to the warning label isn’t helpful.  People should know that they are increasing their risk of every chronic disease associated with mitochondrial damage and oxidative stress when they take a fluoroquinolone.  That would actually be helpful.

Here is the post, on Hormones Matter – http://www.hormonesmatter.com/fluoroquinolone-antibiotics-damage-mitochondria-fda-adds-warning/

 

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Cipro, Levaquin and Avelox are Chemo Drugs

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The entirety of this post can be found HERE.

Here is an excerpt –

When I first heard people referring to fluoroquinolone antibiotics (Cipro, Levaquin, Avelox, Floxin and a few others) as “chemotherapy drugs,” I thought that they were exaggerating or incorrect.  After all, fluoroquinolones are used to treat urinary tract infections, traveler’s diarrhea, anthrax, and other bacterial infections, not cancer. But then I started to do some research into how fluoroquinolones work and I discovered that they cause mitochondrial damage, which leads to oxidative stress and cell death (12), they interfere with the DNA replication process of mitochondria (3), they disrupt tubulin assembly (4) and that they are being investigated for their tumor killing abilities (56).  I also found that all other drugs that have the same mechanism for action as fluoroquinolones – topoisomerase interrupters (FDA warning label7) (topoisomerases are necessary for proper DNA replication) – are used as chemotherapy drugs – topotecanamsacrineetoposide, etc.  Fluoroquinolones are, truly, chemotherapy drugs – they just happen to be used as popular antibiotics. They can kill cancerous tumor cells because, in addition to killing bacterial cells, they also kill eukaryotic cells (89).

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