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!
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:
https://www.youtube.com/watch?v=f0PRE8Ywqx0&feature=youtu.be
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:
- Mitochondrial damage which starts a vicious cycle of oxidative stress and further mitochondrial damage.
- Acute fluoride toxicity.
- Fluoroquinolones chelate vital minerals from cells, including magnesium and iron. These minerals are necessary for hundreds of enzymatic reactions.
- Fluoroquinolones cause a downgrading of GABA receptors and essentially throw people into protracted benzodiazepine withdrawal.
- Fluoroquinolones cause a massive histamine release and mast cell activation.
- They cause collagen synthesis disorders.
- They cause microbiome destruction.
- 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?
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):
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:
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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