Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used:
to treat infections that might get better without treatment or are not severe (such as throat infections);
to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis;
for preventing traveller’s diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder);
to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided.
Please excuse me for not knowing exactly how European drug regulation works (and please correct me if I am wrong), but it looks like the EMA makes recommendations, then the various European governments pass down instructions to their citizens.
The UK government web site gave the following recommendations to healthcare providers:
Advice for healthcare professionals:
systemic (by mouth, injection, or inhalation) fluoroquinolones can very rarely cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice – sheet for patients
do not prescribe fluoroquinolones:
for non-severe or self-limiting infections, or non-bacterial conditions
for some mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease; please refer to revised indications in the Summary of Product Characteristics) unless other antibiotics that are commonly recommended for these infections are considered inappropriate (see below)
ciprofloxacin or levofloxacin should no longer be prescribed for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below)avoid use in patients who have previously had serious adverse reactions with a quinolone or fluoroquinolone antibiotic
prescribe with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants because they are at a higher risk of tendon injury avoid use of a corticosteroid with a fluoroquinolone since co-administration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture
report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store)
I hate that they put “very rarely” into these warnings, seeing as adverse reactions to fluoroquinolones are woefully under-studied and the assertion that these effects are “rare” is based on assumption rather than fact. BUT, these prescriber guidelines, along with the EMA guidelines, are steps in the right direction, and hopefully they will cut unnecessary fluoroquinolone prescriptions significantly.
It is recommended that fluoroquinolone use be restricted for uncomplicated cystitis, Acute exacerbation of chronic bronchitis and of chronic obstructive pulmonary disease, Acute bacterial rhinosinusitis, and Otitis media acute.
The warning labels are still leaving a lot of discretion to doctors/prescribers, and state, “In [indication] [name of product] should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.” even though other parts of the warning label note that FQs should not be used for that particular indication. I worry that this may lead to some confusion among doctors/prescribers.
The new warning label notes that people who have experienced adverse reactions to fluoroquinolones in the past should not take fluoroquinolones. “The use of [INN] should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8). Treatment of these patients with [INN] should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment.”
The possibility of prolonged, serious, and disabling side effects of fluoroquinolones are noted. “Prolonged, disabling and potentially irreversible serious adverse drug reactions
Very rare cases of prolonged (continuing months or years), disabling and potentially
irreversible serious adverse drug reactions affecting different, sometimes multiple, body
systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients
receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk
factors. [INN] should be discontinued immediately at the first signs or symptoms of any
serious adverse reaction and patients should be advised to contact their prescriber for
advice.”
I’m slightly shocked that the risk of tendon problems is just-now being added to European warning labels, but it is one of the changes noted. “Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided. At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with [INN] should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.”
Warnings about peripheral neuropathy are also added. “Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with [INN] should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.”
Permanently disabling effects are noted again, “*Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors.”
Disappointingly, the “Package leaflet: Information for the patient” is full of the words “very rarely” when referring to all the potential effects of fluoroquinolones. Again, the exact rate of adverse reactions to fluoroquinolones is unknown (and may be unknowable because of delayed adverse reactions), and I think that it’s a dis-service to patients to downplay the possibility of these serious and severe effects of fluoroquinolones.
THANK YOU, THANK YOU, THANK YOU to all the European advocates that pushed for these changes in fluoroquinolone warnings and prescribing. You have made an enormous difference, and hopefully rates of fluoroquinolone prescriptions will decrease significantly because of your advocacy.
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!
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!!!
Two guidebooks for getting through fluoroquinolone toxicity
The Fluoroquinolone Toxicity Solution + The Floxie Food Guide:
