Tag Archives: fluoroquinolones

Fluoroquinolone Toxicity News in South Africa – Carte Blanche

I encourage you all to watch, and share, the WONDERFUL news story from Carte Blanche, a South African investigative journalism television series, about the dangers of fluoroquinolones. It’s one of the best pieces of journalism I have seen regarding fluoroquinolone adverse-effects. You can view the story through the Carte Blanche web site, or through Youtube:

Carte Blanche Web Site, “Antibiotic Alert”

Video Link

Carte Blanche tells the stories of pain brought on by fluoroquinolones for three South African “floxies,” Tracy Witelson, Gerald Ludwinsky, and Debbi Kinrade. Their stories are powerful and poignant, and they thoroughly describe the horror of fluoroquinolone toxicity.

The Carte Blanche journalist that interviews the victims of fluoroquinolones, as well as Bayer representatives and representatives of the South African Health Products Regulatory Authority (SAHPRA), does a WONDERFUL job of compassionately framing the stories of the victims, and pushing the pharmaceutical and SAHPRA representatives by asking them tough questions, challenging them, and doing what he can to hold them accountable for the harm done by fluoroquinolones.

In an exchange that is simply wonderful, journalist Derek Watts goes over the newly (2016-2018) highlighted warnings included on the FDA warning labels for fluoroquinolones (including a warning that notes that fluoroquinolones can cause permanent disability, one that notes that the risks of fluoroquinolone use outweigh the benefits, one that notes that fluoroquinolones cause blood-sugar irregularities and mental health adverse-effects, and one that notes that fluoroquinolones increase the risk of aortic aneurysm and dissection) with Dr. Naren Jairam, the Bayer Pharmaceuticals representative. Dr. Jairam dismissively asserts that these warnings are nothing new. Watts responds by asking Jairam why Bayer hasn’t been communicating the dangers of fluoroquinolones with doctors (much less patients). Jairam claims that Bayer supports responsible use of antibiotics and that Bayer has advocated that fluoroquinolones not be used as first-line antibiotics. Watts CALLS HIM OUT and says, “That’s not true,” and notes that millions of prescriptions for non-life-threatening infections are being given all over the world. It is truly wonderful to see a quick-witted journalist asking tough questions of pharmaceutical company representatives, and calling them out when they lie and mislead.

In another exchange, Watts asks Jairam, “Is your intention to obfuscate or clarify?” VERY good question – thank you for having the chutzpah to ask, Mr. Watts!

Watts also confronts Eric Chauke, Bayer’s Head of Regulatory Affairs, by asking him to show that Bayer is communicating the risk of harm by fluoroquinolones with doctors. Chauke shows Watts some general pamphlets on antibiotic stewardship, and Watts pushes back – noting that there is nothing in what Chauke is showing him that adequately communicates that fluoroquinolones can have “dreadful side-effects” or that adequately communicates that fluoroquinolones should not be used as first-line antibiotics.

Watts also asks Professor Marc Blockman, a representative of the South African Health Products Regulatory Authority (SAHPRA), some tough questions. He asks whether or not the SAHPRA warnings are adequate, and why SAHPRA can’t send a communication to doctors stating, “don’t prescribe these drugs unless it’s life threatening and there is no alternative?” Patient advocates have been asking the same thing for years, and it’s nice to hear a journalist ask this question to a drug regulator.

I love how tough Watts is on the Bayer and SAHPRA representatives. He is doing a wonderful job at being a journalist that brings to light stories of victims, and holding those in-power responsible for their role in victimizing people.

Please watch and share the Carte Blanche piece on fluoroquinolones. It’s wonderful, and it would be great for it to be internationally “viral.”

*****

 

EMA Hearing on Fluoroquinolone Toxicity Part 3

In the first post about the EMA hearings (EMA Hearing on Fluoroquinolone Toxicity Part 1) I summarized the testimonials provided by Elizabeth Carmouche, Manex Bettan Arguinzoniz, Richard Cooknell, Markus Hamedinger, and Miriam Knight (who also spoke on behalf of Raymond Miller and Geoffrey Robinson), and in the second post about the EMA hearings (EMA Hearing on Fluoroquinolone Toxicity Part 2) I shared the written testimonies of Julie Le Normand, Elsa Leitão, Jarosław Linka, Andrea Noya, and Joshua Sutton. Again, in part 3, I will share the written testimonies submitted to the EMA by the people who testified. I encourage everyone to read the submissions in full, and to watch the video of the testimonies–they are moving and poignant:

Speaker 11. Miriam van Staveren, The Netherlands

Dear EMA,

I am a physician from the Netherlands. I am also badly affected by the side effects of levofloxacin.

In July 2014 I went for a holiday on the Canary Islands. I was prescribed a 6 day course of levofloxacin for an inner ear infection and a sinusitis. During the treatment I noticed my Achilles tendons started hurting. I thought it was due to the fact that I had exercised too much: I took tennis lessons, I hiked and swam a lot, played ping pong, engaged in water aerobics, and dancing.

Travelling home, I felt all right. But after a week, my Achilles tendons started to hurt again, so severely, that I suddenly could not walk anymore. After yet another week my ankles started hurting as well. Followed by my knees, my left shoulder and both my thumbs. During the next 6 months I also developed (amongst others): muscle cramps and trembling (fasciculation’s), neuropathy, joint pain and swelling, night sweats, severe itching, hair loss, intolerance against even the lightest exertion such as taking a shower, intolerance to light, profound insomnia and very painfull dry eyes.

I became depended on a wheelchair and crutches. I was in pain day to day. I recently even lost my license as a physician due to the fact that I could not work anymore.

An MRI showed knee cartilage damage and a large meniscus tear, with fluid in both knees. My Achilles tendons were thickened as if I had been a Marathon skater. I had visible skin damage to my ankles and lower legs. My orthopedic surgeon was reluctant to operate me. Which, as you know, is rather remarkable for a surgeon.

Yet my surgeon wanted to explore what was going on in my body before he dared to operate on my knees. This is why he referred me to a professor in an University hospital in Amsterdam. This to perform a medical evaluation by a team of specialists: a toxicologist, a geneticist and internist and so on.

Unfortunately, after this rather optimistic beginning of my medical condition being believed, I could not find one single doctor who was familiar with the symptoms of the delayed and long lasting side effects of the fluoroquinolone antibiotics. The above mentioned professor told me he couldn’t help me. Not even a clinical pharmacologist specialized in side effects of medication had heard of these severe and lasting side effects. I had to refer her to a professor from the university of California to convince her my symptoms were real and caused by levofloxacin.

In total I visited at least 7 specialist of 3 different top teaching hospitals in Amsterdam. None of them could help me, most could not believe my symptoms were due to taking levofloxacin. I remember once a GP asking me: “did you sprain your ankle?” This because my ankle was very swollen and painfull.

No matter how much peer reviewed literature I showed, my doctors could not believe my symptoms were caused by levofloxacin nor were they able to help me. Even if believed, there hasn’t been found a cure yet against the persistent and debilitating side effects of fluoroquinolones also called fluoroquinolone toxicity syndrome (FQT).

I have tried to warn various health care organizations in Holland involved in medication side effects. They all told me I was the first patient they ever met to have these persistent side effects. I tried to publish an article in a medical Dutch magazine. Sadly my article was refused because the editors deemed it not relevant for the Netherlands. As I agree, in the Netherlands antibiotics are prescribe quite reluctantly, however I got to know various other patients in my home country.

I performed a literature search and wrote a “Dear doctor” letter which I published online in august 2015. This letter was also sent to the FDA hearing about fluoroquinolones in November 5th 2015. My letter was meant for patients to show to their own doctors.

I learned there were many patients in various countries in the world desperately looking for knowledge, validation and help. They were gathered in Facebook groups. Some of those patients are also working in the medical field: medical doctors, nurses or pharmacists. They were all as astonished as I was that a few pills can cause such havoc. One medical doctor told me she thought the side effects of fluoroquinolones are much worse than the side effects of Chemo. On a certain moment she suffered so much she considered to go to a clinic in Switzerland to be euthanized.

Not being able to help other patients felt very frustrating for me. Up to this day I carry the stories of many of them with me in my heart. Some of those patients committed suicide in their despair. Almost all of them lost their previous active life and or jobs. I heard many of them were too ill to come to speak here today. Even too ill for a teleconference. I can understand this, as four years ago I would not have been able to be here myself, due to the side effects. I have been in contact with many patients. In Europe: Italy, Germany, Great Britain, Spain, Switzerland, Finland, the Netherlands, Sweden, Austria, Hungary and Belgium.

In the fall of 2017 I was approached by an author of Nature magazine. She was told I was a physician living in Europe who was knowledgeable about the side effects we are speaking about here today. She wrote an excellent article about the syndrome called fluoroquinolone associated disability (FQAD: name given by the FDA). Yet even after the article in Nature was published in the March 21th issue I was not able to get Dutch doctors interested. This detached attitude is no exception in the European medical field. I almost never heard of a patient being believed their symptoms are from taking the antibiotic this hearing is about.

This is why I am very grateful I was invited to speak at the EMA hearing. I know EMA is influential and I know you already put a lot of time in studying these side effects.

It is my strong belief that there is no safe use of fluoroquinolones. That is, until further in vivo human research can select those who will be harmed by taking them. It is very well possible that anyone can be affected, although some people are probably more vulnerable than others. Some patients are hit after having taken this antibiotics multiple times. Some are hit after just 2 pills. Obviously there is a personal threshold.

Further research should not only emphasize on safe use, – if at all possible -, but also on the exact mechanism of harm done. This to help those who are currently suffering from this complicated syndrome, which should get a diagnostic code. Firm upgraded warnings and full information about the debilitating side effects should be issued broadly in Europe as soon as possible. Possible mitochondrial toxicity should be included in the warnings.

Its use should be reserved for serious life threatening infections that do not respond to any other treatment. Any such infection should be cultured first. Patients should always be fully informed about the risk to become disabled after the use of a fluoroquinolone antibiotic.

Speaker 12. John Crowley, Luxembourg

My name is John Crowley, Im Irish but living in Luxembourg and the story Im about to tell you I would not have believed was possible if I had not experienced myself.

In 2009 I was in an accident which left me with a stricture of my urethra.

Over the next 9 years whenever I suffered from pain in penis my urologist put me on Ciprofloxacin as he told me it could be an infection and this would make my condition worse. He unfortunately never sent me for tests to verify if I had an infection.

In October 2014 (aged 38) while taking Ciprofloxacin I developed a sharp burning pain in my right Achilles tendon. The next day I felt the same in my left leg. At this point I was barely able to walk and went to the emergency room at my local hospital.

I was put on crutches and told this was a common side effect and would disappear in a few weeks.

Next up I developed pains in my arms and hands.

I went to an orthopaedic specialist and was diagnosed with Achilles tendonitis in both legs, golf and tennis elbow in both arms.

After months of physio I saw limited improvement and was sent for an MRI scan which confirmed the above diagnosis. 2 and a half years later the tendonitis is still visible via MRI.

Unfortunately the tendonitis remains and in the interim I also have developed tendonitis in both knees. I am no longer able to participate in sports and am in pain in my daily life constantly having to use ice to dull the pain. Even simple things like playing football with my children or bringing shopping bags into the house are no longer possible.

I work in an office and have had to change to a special ergonomic mouse as I can no longer use a standard mouse. I find it difficult but to date have been able to hold on the my job. If I was working in a manual profession such as a carpenter there is no doubt I would now be unemployed.

The next side effect I experienced was a pain in my arm which felt like an electric shock. This was followed by involuntary movement of my arm at night time which lasted for a period of several months and was very scary.

I went to see a Neurologist but by that time I got an appointment and took tests my symptoms had receded and my tests came back negative. The dr was unable to explain what might have happened.

Finally I have no evidence to link this to Ciprofloxacin but I have also developed the following over the past 3 years:

i. Chronic dry eyes (I need to put drops in my eyes throughout the day and a special cream at night) ii. Eyes not focussing correctly iii. Dry skin iv. Dry ears v. Damage to my hearing vi. Stomach and digestion issues leading to acid reflux for which Im now on PPI’s vii. Insomnia viii. Less control over my bladder which requires me to urinate 1-2 per night

There is no history of any of the above in my family and my dr’s are unable to explain the root cause. Perhaps just bad luck but I don’t believe a healthy man at my age who always ate and exercised well could have so much bad luck in such a short space of time.

I have no doubt quinolones are a useful tool and have their place in the dr armoury but I believe it is used too frequently without a proper understanding of the side effects.

While some dr’s have been very sympathetic to my plight the vast majority to be quite frank did not believe that it was possible that a quinolone could do this.

My recommendation would be for Dr’s to be formally made aware of the dangers by the regulatory body, to be issued with a very strong recommendation that this only be used where alternatives were not available and finally for much enhanced warnings on the packaging.

I read that this medication could cause tendonitis on the label – it didn’t say anywhere that this would last over 3 years (and at this point probably for the rest of my life). That’s just not right and needs to be addressed.

Answers to 3 PRAC questions:

I have no doubt quinolones are a useful tool and have their place in the dr armoury but I believe it is used too frequently without a proper understanding of how dangerous the side effects are One dr summed it up well when he said you dont use a bazooka to kill a mouse in your house. While you would no doubt get rid of the mouse the collateral damage would be too great and I believe a similar logic can be applied to quinilones.

While some dr’s have been very sympathetic to my plight the vast majority to be quite frank did not believe that it was possible that a quinolone could do this.

My recommendation would be for Dr’s to be formally made aware of the dangers by the regulatory body, to be issued with a very strong recommendation that this only be used where alternatives were not available (and if prescribed risks to be clearly explained to patients) and finally for much enhanced warnings on the packaging.

I read that this medication could cause tendonitis on the label – it didn’t say anywhere that this would last over 3 years (and at this point probably for the rest of my life). That’s just not right and the labelling needs to be addressed (for example in the US the packaging carries a black box warning).

Speaker 13. Enikő Pongrácz, Hungary

Dear PRAC,

I was prescribed in October, 2014, ciprofloxacin 500mg 1/day for UTI, and in March, 2015, Ciloxan ear drops for Otitis media. After 5 weeks in both cases extreme high blood pressure and debilitating headache appeared, which very hardly could get back in control.

And the rest came after each…Gained +30 kg in 3 month, hypovolemia, sudden hair greying in 3 weeks, my hair can not be dyed ever since- low cardiolipin, low autophagy. My ears and nose are clogged, dry- Sjorgen Syndrome, Tinnitus loud ever since, sensorineural hearing damage, Myoclonus Tympani-Stapedius-Eustachian tubes-Palate, sleep apnea and insomnia. Carotid damage, Lymph nodes inflamed to double. Eye floaters, foggy vision, dry eyes, uveitis, vision worsened, frequent morning cornea bleedings due to high blood pressure during sleep reaching 200/150 and very high pulse, supratentorial flairs = mini stroke, shrinking frontal lobe, constricted hypothalamus arteries =release hormones problems leading all hormone problems, cortisol, estrogen, ovarian cysts several times, uterus myoma, GERD, SIBO, hiatus hernia, gallbladder blocked, colon pain, diarrhea, colon/fecal incontinence, urinary incontinence, tendonitis-capsulitis, insulin resistance, EHS (electro hyper sensitivity, or microwave sickness is due to mitochondrial damage), detox blocked still, not sweating for 2 years. Mitral insufficiency, LBBB, peripheral neuropathy (one hand and one leg), changed blood count, shifts in over range and under range. Reactivated EBV and HHV ever since, became chronic. Frey syndrome, teeth dentin browned, can not be cleaned and about 12 cavities ever since and 1 extraction. Multiple chemical sensitivity- to foods, smells, dust mites and suffocation from detergents and cleaning products. Several ER visits due to high blood pressure and angina. Continuous brain fog, ears and head pressure.

Since than I am half deaf, half heart and half limbs functioning.

I can not work anymore, previously I was business consultant, traveling for business and for private as well, doing all kind of dog-sports.

My life after cipro poisoning in sum its a total wrack: health-wise, financially and socially as well. I am disabled, several unrecoverable damages, however in Hungary there is no BNO code for fluoroquinolone toxicity and neither for electro hyper sensitivity – moreover doctors and healthcare deny both. All other symptoms I have are not subject to disability one by one. Misdiagnosed in row.

Can eat only bio, GMO free, no processed foods and take only additives free supplements to avoid side effects and diarrhea, with the significant extra costs of these products.

Natural and phisio-therapy and American doctor consultations are also significant costs.

Due to Electro-Hyper-Sensitivity can not go anywhere public (workplace included) only in nature and if 5G will be installed soon, I will have to move to a farm, in total isolation.

One hour shopping, a doctor visit, MRI/CT/ultrasound or any administrative sorting (bank, municipally, etc) is reactivating any virus I ever had (from contamination or from vaccine) – latest was shingles which I struggle since mid April.

Due to electrosmog (wifi, cell towers) following are also forbidden: public transportation, motorways, hotels, vacation, restaurant, shopping, café, cinema, theater,…

Due to peripheral neuropathy I can fall, can not held properly, I mistype.

I get tired very quickly, I can not run at all, I am not able to held my dog even for walking, while previously had done defense activity with him. Housework is limited to max one hour with protection mask and googles.

I lost connection to my friends- since can not meet them anywhere in public as before.

I vegetate and hope only, that PRAC will ask fuoroquinolone producers to research and develop the way by which we can expel this poison from our body, to stop further continuous damage occurring and repair damaged mitochondria. According to a research, ciprofloxacin stays forever, moves with exosomes at cell apoptosis so damage continues for lifelong –

https://www.researchgate.net/publication/319129045_Antibioticinduced_release_of_small_extracellular_vesicles_exosomes_with_surface-associated_DNA

Another research shows MRSA decreasing while stopping FQ use in hospitals:

https://www.consumerreports.org/hospitals/surprising-remedy-deadly-hospital-infections/

Post PRACs review all doctors, veterinarians and pharmacists should be noticed, and a health insurance protocol should be developed in each country for treating FQT.

Mitochondrial diseases’ major cause are medications, patients are misdiagnosed and not too much is done for them in EU.

https://mitochondrialdiseasenews.com/2018/05/11/multiple-consultations-tests-and-misdiagnosismark-mitochondrial-disease-odyssey-surveyfinds/?utm_source=Mito+Disease&utm_campaign=ccfc61e1a8- RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_fdcf314ce5-ccfc61e1a8-72144013

https://www.ncbi.nlm.nih.gov/pubmed/?term=Medicationinduced+mitochondrial+damage+and+disease

https://mitochondrialdiseasenews.com/2018/05/17/ecrd2018-eu-must-do-more-for-rare-diseasepatients-eurordis-leaders-say/?utm_source=Mito+Disease&utm_campaign=ccfc61e1a8- RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_fdcf314ce5-ccfc61e1a8-72144013

All severe adverse reactions must be black-boxed. I am confident that no disabling, debilitating (unrecoverable damage causing) medications should be on the market, until a recovery method is not found. Fluroquinolones should be withdrawn from public use, kept under lockers for Antrax or similar severe cases only, as misdiagnoses is very frequent ending in catastrophic consequences.

In Hungary pre- and postoperatory always FQs are used. Since I’ve been affected, my mother was prescribed FQ in the ER, 2 days later by her doctor as well, and she had ‘only’ allergy, no conjunctivitis. My dog diagnosed with prostatitis was given FQ as first choice, which I denied, but soon turned out it was due to excess estrogen from chicken meat. These are ‘only’ 2 examples from my family, but could give many examples from my surroundings as well.

What do you think is compensating for all these suffering and ruined life?

Thanks a lot for this hearing opportunity ! 2018. June. 01.

Dear PRAC,

Please find below inserted my answers related to Fluoroquinolone and Quinolone EMA Public Hearing and please consider them. Within the scope of this review and based on your experience with quinolone and fluoroquinolone treatment:

1. What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?

A chemotherapy drug should be the last choice given, not the first, therefore should be available only in hospital care. Should never ever be given as a pre or post -operatory medicine – now is the first choice. Should never-ever be given to kids or adults for simple otitis or conjunctivitis or any other usual disease – now its the first choice. Should be given only after a bactericidal test. Same valid for veterinary care as we do not want our pets dead, or do not want to eat FQ infested meat ( see the study with pray-birds dead in Spain, due to eating FQ infested animal corps).

2. What is your view of the risks associated with quinolone and fluoroquinolone use?

All side effects should be mentioned on the patient info label. Mitochondrial and DNA permanent grave damage and unknown elimination time should be mentioned as well, according to latest research available. ( in animal research after 520 days FQ was still present)

3. In your opinion, what further measures could be taken to optimize the safe use of quinolones and fluoroquinolones?

All countries should recognize and compensate the patients affected by FQ, FQAD should be recognized and compensated accordingly and all medical and pharmaceutical and veterinary staff should be retrained according to new restrictions ASAP in place. As a main unknown side effect, EHS/microwave sickness should be recognized as well by all countries.

Manufacturers must be made responsible to research remedies for counteracting the damages and finding ways for quick elimination from the cells.

Thanks for your consideration!

 

 

EMA Hearing on Fluoroquinolone Toxicity Part 2

In the first post about the EMA hearings (EMA Hearing on Fluoroquinolone Toxicity Part 1) I summarized the testimonials provided by Elizabeth Carmouche, Manex Bettan Arguinzoniz, Richard Cooknell, Markus Hamedinger, and Miriam Knight (who also spoke on behalf of Raymond Miller and Geoffrey Robinson). In Part 2, and all subsequent posts about the EMA hearings, rather than summarizing my take on the testimony given, I will quote people directly from the written submissions that they provided to the EMA. Please note that not everything said in the hearing is included in the written submissions, and significant valuable information and insight can be gleaned from listening to the hearing. You can view the entire hearing through the following video:

Speaker 6. Julie Le Normand, France

1. What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?

2. What is your view of the risks associated with quinolone and fluoroquinolone use?

3. In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?

My name is Julie Le Normand, I’m 37, I’m a French citizen and I am not representing any organization.

Back in November 2017, I had a terrible experience with levofloxacin (TAVANIC 500 mg, to be exact, twice a day for 10 days). That was the first time I ever took fluoroquinolones in my life, and it will certainly be the last.

Quinolones and fluoroquinolones (hereinafter referred to as Q & FQ) are far too broadly prescribed for cases where much less intense medicine would more than suffice for an efficient treatment. Having spoken with numerous people from across the world suffering from their adverse effects, I have learned that Q & FQ have been prescribed for everything from non-complicated urinary tract infections and sinusitis all the way to… anthrax exposure and the plague. I, for example, was prescribed a course of Levofloxacin by my general practitioner for a case of bronchitis/sinusitis at the end of November 2017. I would like the committee to know that I was never warned about the possible severe, longlasting side-effects of this medication by the doctor, nor by any other medical staff. It only took me two days on Levofloxacin after which I had no choice but to stop the medication because of the sudden onset of its adverse effects.

The manufacturers’ notice of the risks associated with Q & FQ is listed merely as “rare.” My experience—and those numerous others who have suffered from them—can attest to the fact that the risks of use of Q & FQ are anything but rare, contrary to what all of us have been led to believe. Please allow me to kindly state to the Committee that I took merely 4 pills in total of levofloxacin over two days, 7 months ago. For some, the adverse effects affecting the musculoskeletal and/or nervous system occur weeks or even months afterwards, which makes it even more difficult to connect the delayed symptoms with a course of antibiotics taken several weeks/months before. For me, the onset was as immediate as it was intense. I started to feel an extreme weakness in my legs. It was so bad that I could neither stand up on my feet nor walk anymore. I cannot do justice to you in describing just how uncomfortable the sensations inside my legs were. It felt as if bugs were crawling on them. Both my ankles and my Achilles heels started to hurt and swell. I could hardly breathe. My blood pressure rose dramatically, and I was overcome with a feeling of confusion and agitation. The experience was so bad that afterwards, I was completely bedridden for more than 3 weeks and on sick leave from work for 6 weeks. I felt depressed. And 7 months out, I still feel weak emotionally. My face has aged suddenly though I’m 37. I did not used to be this way. I used to be a very healthy person. I loved hiking, skiing. I am still a mother to 2 children both under the age of 5. But now I am limited in my physical and emotional capacities, and this is extremely upsetting and unfair. I will say that there have been some concrete improvements since the episode, but a part of me still wonders whether I will ever be able to fully heal from this “toxicity syndrome.” I have seen several doctors, each of whom have been helpless with the various symptoms I experienced. Long-lasting symptoms simply after a few pills of levofloxacin.

Please allow me to state for the record that I’m convinced Q & FQ should be limited only to life or death situations as their adverse side-effects far exceed what they can otherwise treat! In fact, I fear there is no such thing as a “safe use” of Q & FQ as the side-effects seem to be very common, almost the norm. Please allow me to reiterate that in my view Q & FQ should ONLY be prescribed at the hospital in certain circumstances with very cautious care and a thorough monitoring of any possible side-effects. General practitioners should not be able to prescribe them anymore without identifying the bacteria to treat, and in any event, not as a secondary intention but rather as a last resort treatment.

If I may add a final remark, I believe that the topical Q/FQ (such as eyedrops, ear drops) should also be included in this safety review as they are known to cause adverse reactions as well, that can be as severe as those triggered by the oral or IV antibiotics.

I do hope that the outcome of this Public Hearing will lead to:

1. An acknowledgement of a so called FQ associated toxicity syndrome/disability within Europe. To my view, there is an urging need that the EMA acknowledges the existence of a so called FQ associated toxicity syndrome/disability (FQAD, like the US Food and Drug Administration did a couple of years ago).

2. If not a complete BAN of FQs, at least a STRONG restriction of their use within Europe This would be for sure a historic choice (much stronger that the current “black box warnings” used in USA) and would give Europe the leadership in FQ toxicity awareness.

Thank you for your time and consideration and for the opportunity to present my experience to the Committee.

Speaker 7. Elsa Leitão, Germany

My name is Elsa Leitao. I’m from Portugal and I’m currently living in Germany where I work as a scientist in the field of human epigenetics.

I’m 39 years-old and until three years ago I was fairly healthy. Then I was prescribed Ciprofloxacin to treat a regular urinary infection. I had no further warning from my physician about the special risks associated with this drug. After a few days I developed side effects: joint pain, muscle pain, difficulty in walking, lack of strength and general tiredness. It took me several months until I started feeling better but I never got back to my previous health state. I haven’t been able to run longer distances again due to the fragility I still feel in certain tendons. Even after three years, I have sporadic episodes of severe joint pain that I believe are related to the ingestion of certain types of food that I became unable to tolerate.

I think quinolones and fluoroquinolones should only be used in life threatening conditions such has extremely severe infections. These drugs should be avoided when other treatments are possible. I believe that patients prescribed with these antibiotics are in great risk of becoming sicker than before the treatment. Moreover, the side effects take much longer to subside than the initial illness would take to disappear with other treatment and may even become permanently debilitating.

There are a few measures I think should be taken to optimise the safe use of these drugs: 1) Physicians should be better instructed about the severe long lasting side effects the administration of these drugs might have; these instructions should be clearly passed to medical school teachers, medical students and working physicians, so all links in the chain can simultaneously acquire this knowledge. 2) Physicians should inform the patients about the potential toxicity, so the patients can be alert to the appearance of potentially alarming signs. 3) Packages should contain clear warning labels. 4) The products information should be changed with regard to the use of these drugs to the treatment of non-severe infections.

Although this public hearing is more focused in trying to improve the future use of these drugs, I think the past shouldn’t be forgotten nor the patients whose life was most severely and permanently affected. In this regard, efforts should also be taken in understanding how to treat these patients.

Speaker 8. Jarosław Linka, Poland

1) What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?

Fluoroquinolone (FQs) antibiotics are currently one of the most frequently prescribed drugs in Europe and play a very important role in treatment for bacterial infections, such as pneumonia, sinusitis, bronchitis, urinary tract infections, as well as for prostatitis. However, FQs are extremely toxic, have high potentials for adverse effects (AE) and associated with potentially long-lasting, frequently permanent, serious sides effects. Adverse reactions (ADRs) are often delayed for some weeks or months after cessation of FQs drug therapy, which makes it extremely difficult to make a correct medical diagnosis and apply symptomatic treatment. They belong to the group of broad-spectrum antibiotics, effective for both gram-positive and gram-negative bacteria. FQs employ their antibacterial effect by preventing bacterial DNA from unwinding and duplicating through inhibition of their topoisomerase and gyrase, which differentiate them from other common antibacterial agents. This mechanism places them closer to chemotherapy drugs then other antibiotics, which mostly interfere with specific steps in homeostatic cell wall biosynthesis. As a result of this broad-spectrum and misunderstanding of their safety profile, doctors in Europe consider them as a safe treatment option and prescribe them even as an empirical first line antibiotics therapy. This is leading to an overuse of FQs, and in consequence tens of thousands of people suffer by them each year, yet nearly all those damages remain misdiagnose or undiagnosed. Patients after FQs ADRs frequently are diagnosed as having Lyme disease, multiple sclerosis, neuropathies of every kind, lupus, rheumatoid diseases and most often fibromyalgia. Only a handful of doctors are aware of a devastating effects of FQs. The rest are uninformed and often deny the existence of fluoroquinolone associated disability (FQAD).

2) What is your view of the risks associated with quinolone and fluoroquinolone use?

According to the latest research and available literature, FQs toxicity results from many causes, including the formation of reactive oxygen species, and generation of oxidative stress damage of the mitochondrial DNA, as well as from the chelation of metals and a change in gene expression. These mechanisms explain the reason why FQs are often reported, to cause permanent and serious sides effects to: tendon, muscles, joints, nerves and other organs. Other long-lasting problems involve the cardiovascular system (QT interval prolongation), musculoskeletal system disorders (arthropathy, muscle weakness, joint pain and swelling), chronic fatigue and diabetes mellitus. Moreover, FQs have recently been discovered to induce delayed adverse neuropsychiatric effects including dizziness, sleep disturbance, anxiety, suicidal thoughts, hallucinations, psychosis, depression and recurrent mania. All the side effects should be mentioned on the patient info label, especially including psychiatric and potential delayed mitochondrial toxicity (like mitochondrial DNA depletion and mutations.)

3) In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?

The overuse of FQs and the growing number of reports on ADRs often leading to the fluoroquinolone associated disability (FQAD) is the main reason to avoid FQs when other safer alternatives are available. FQs should only be used as the last resort, exclusively in a hospital, by a well trained specialist. Unfortunately routine blood and urine tests are generally non-contributory to diagnoses of FQ’s ADR or FQAD, so specific molecular and genetic tests should be provided as quickly as possible. Special studies are necessary to find genetic factors underling susceptibility and the genotypes predisposing to ADRs. Multicenter clinical trials on long-lasting FQAD in large groups of patients are also required. Immediately, the basic guidelines and standard treatment methods for ADR and FQAD should be developed. This can’t be left to desperate patients and only several aware doctors who try to help them, like it was in my case. After one year of visiting numerous clinics in Poland, Germany, China, and USA I have finally found doctors, who were willing to help me and are aware of the FQ toxicity syndrome. Based on published data analysis and subsequent empirical searching, an individualised treatment plan was developed, which significantly reduced or even reversed some of my damage caused by Levofloxacine. Although, after three years my quality of life is better, a lot of environmental factors can induce intermittent episodes of symptoms. I am still suffering from chronic fatigue, Achilles and other tendons tendinopathy, multilevel degenerative disc disease, peripheral and small fibre neuropathy, uncommon food sensitivities, muscle weakness and headaches. A Review of currently available knowledge of possible ways to treat of FQAD, inspired by my case, was published last year in the Oxidative Medicine and Cellular Longevity under the title: “Treatment of the Fluoroquinolone-Associated Disability: The Pathobiochehemical Implications”

I hope that a PRAC meeting will set new restrictions for FQs and new procedures of their use only in hospitals, under long-term supervision and as a last resort treatment. Limited action from EMA such as just copying FDA’s warning from June 26, 2016 will probably keep the current status quo for their use and spreading of their devastating delayed side effects, what we can still observe with the growing number of cases of FQAD from the United States.

https://doi.org/10.1155/2017/8023935

Speaker 9. Andrea Noya, Italy

As someone who’s suffered and is still suffering serious side effects from a fluoroquinolone, prescribed to me more then a year ago, I’d like to share my experience, in the hope that more consciousness would be applied, when using these types of drugs and also in the hope of bringing these side effects to the attention of the many doctors, that still seem to ignore them.

Answering the questions:

1. I think quinolones and fluoroquinolones are powerful and effective drugs that should be only prescribed for serious or life threatening infections.

2. The risks, in my opinion, exceed the benefits. A patient shouldn’t suffer serious or disabling side effects from a drug prescribed to treat or even prevent a common infection.

3. In my opinion, more restricting laws should be applied to this class of drugs and it should be mandatory for doctors to be better informed and trained on the use of quinolones and fluoroquinolones.

(Please note that Andrea Noya goes into significantly more detail about his experience with fluoroquinolone toxicity in his testimony.)

Speaker 10. Joshua Sutton, UK

My name is Joshua Sutton and I am a business student at Sheffield Hallam University.

I would like to begin by saying that there is a place for Fluoroquinolones in modern medicine, and the use of them in a proper manner could be very effective. However, the current use of them is far too frivolous and exceptionally dangerous. These drugs have such strong capabilities of causing major damage, as two days after the treatment of Ciprofloxacin for an unconfirmed and nonurgent infection my neurological health greatly deteriorated. The impact that these drugs have had on my life is beyond belief.

My view on the risks of Fluoroquinolones is that they very often outweigh the benefits, especially for unconfirmed and non-urgent infections. I was prescribed Ciprofloxacin on the 5th June 2017 by my GP. It was the 17th June when I first realised something was wrong, where my vision became very slurry and I felt very disorientated. This was accompanied by a horrible brain fog sensation that has never gone away, extreme light sensitivity and then walls of black snakes down the walls which ended up being the development of eye floaters.

Starting on the next day, the 18th June, I developed a terrible tremor and loss of sensation in my hands and feet where I quickly lost the ability to do even the most basic of tasks; tying my shoe laces, holding a knife and fork or even dressing myself. I would have excruciating deep rooted pains and aches down my glutes and hamstrings down into my feet, and the same down my arms into my hands that would refine me to my bed. The tops of my hands and feet would also be extremely sore, where moving my toes or fingers or clenching a fist would be agony.

I have burning and tingling pains and sensations all over my peripherals and head and face, and my limbs would consistently go numb. I couldn’t hold my phone up to use it as my hands and arms would quickly go numb and I would awake every morning with both my arms hanging by my side completely dead. I would and still get burning sensations down my back and limbs that makes even the weight of a cotton t-shirt against my skin excruciating. In addition to this, I would also find it impossible to empty my bladder and would have to strain to do so even a little bit.

Onto the fatigue and weakness, I would be so weak to the point where I couldn’t turn over a chicken breast in a frying pan or pick my feet up as I was walking so I would simply trip up over my own feet regularly. I would find it impossible to complete daily tasks. I was very reliant on my Mum to look after me and care for me during this period and I have had to make some major lifestyle adjustments in result of all of this. I am still very fatigued to this day and have great difficulty concentrating on anything. My cognitive abilities have been greatly affected by all this.

Alongside this, I have also been seeing a Cognitive Behavioural Psychotherapist to help me handle the anxiety involved with these symptoms.

Moving on, my opinion on further measures to optimise the safety of Fluoroquinolones should be to discontinue the use of them for unconfirmed and non-urgent infections, only allow GP’s to use them as a last resort, perhaps if the patient has allergies or sensitivities to many other alternative antibiotics. Also, the use in hospitals should also be as a last resort, and any prescribing doctor should not only be fully aware of the adverse capabilities of Fluoroquinolones but also discuss any adverse reaction symptoms with the patient so they are well informed because if they begin to have adverse symptoms during their course and continue taking them they are going to be very unwell for a very long time.

Fundamentally, this is all an iatrogenic catastrophe and there needs to be immediate regulation to mitigate these risks involved.

Ciprofloxacin took away my health, my fitness and my sanity, and for that, its unforgivable.

*****

Dominick Cruz’s Cipro-Induced Tendon Rupture

Dominick Cruz, two-time UFC Bantamweight Champion, was floxed by Cipro. He describes his experience in episode #921 of Joe Rogan’s podcast, The Joe Rogan Experience.

Starting around minute 53 in the video above (and 1:02 in the downloaded podcast), Dominick Cruz states:

I did research later, I’m now basically a doctor to figure all this stuff out because of all the injuries I’ve been through. But 3 weeks before I fought Mizugaki I had a staph infection on my right thumb that popped up. So I took an antibiotic called Cipro. Now, me trusting the doctors and me not – it’s my own fault, not the doctors fault – I should have read the hazards of the antibiotic. But you kind of trust the doctors and assume, why would he give me something bad, right? Well, Cipro has an after-effect for six months after you ingest it that it weakens your tendons, so it makes them soft like real putty. And so I took it three weeks before the fight – that made it about 2 months after I ingested the Cipro – I was throwing a left high kick – I’d never had a problem with my right knee ever in my entire life, and it just popped throwing a high kick. I pivot on my right leg, throwing my left leg high, and it just popped and I knew right away, obviously, ’cause I’ve done it twice, that I’d blown it out. I remember literally, blowing it out, sitting on the floor, and the guy that I was drilling with was like, “What’s up?” and I was like, “I just blew my knee out.” He’s like, “What? Nothing happened!” It was crazy. It was a weird feeling. What was even weirder was the peace I had sitting there – not even caring. I literally was just – I remember blowing it out and sitting on the ring like, I told Eric, “Come here – You ready for another 9-month ACL reconstructive surgery?” and he’s like, “What? What are you talking about? Your knee’s fine.” I’m like, “No, I blew it out just now.” He’s like, “no you didn’t.” I said, “yes, I did.” And, that was it. So, I start again. I started the rehab again.

The good news for Dominick Cruz, and the hopeful take-away for all of us who have been hurt by fluoroquinolone antibiotics, is that after he went through surgery to reconstruct his blown-out ACL, and after 9 months of rest along with physical therapy, he returned to fighting and won the UFC Bantamweight Championship in January, 2016. Being able to fight in the UFC after experiencing a Cipro-induced tendon injury is huge, and we should all be inspired by Dominick Cruz’s comeback.

I have never talked to Dominick Cruz, nor have I heard anything about his story other than what he shared in episode 921 of The Joe Rogan Experience, so, what follows involves some conjecture. With that disclaimer noted, here are some thoughts about Dominick Cruz’s experience.

Why did Dominic Cruz’s doctor give a professional UFC fighter, an elite athlete, a fluoroquinolone prescription???? What is wrong with his doctor? Is his doctor not aware that tendon ruptures are a well-documented effect of fluoroquinolone antibiotics? He or she should be. It’s on the black box warning label for Cipro, and all other fluoroquinolones. The first sentence of the black-box warning for Cipro, in 2016, stated, “Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages.” Did Dominick Cruz’s doctor think that healthy and strong tendons weren’t necessary for Dominick Cruz to do his job as a UFC fighter? Did Dominick Cruz’s doctor think that it was okay for him to experience tendinitis and tendon ruptures? Maybe Dominick Cruz’s doctor is under the impression that UFC fighters don’t need healthy, strong, flexible, and durable tendons. It absolutely blows my mind that an ignorant fool of a doctor could give a UFC fighter, an elite athlete, and a man with a history of tendon injuries, a drug that has the documented effect of destroying tendons. It is unacceptable for a doctor to prescribe Cipro, a drug that has been shown to cause disabling tendon injuries in thousands of people, and which permanently alter the structure of rat tendons and causes permanent lameness in beagle puppies, as well as permanent disability in humans, to a man whose entire livelihood depends on his ability to use his tendons. That doctor is a dangerous ignoramus, and he should be fired then sued for every penny he’s got.

Every doctor who works with athletes, especially professional athletes, should read the article “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the
Athletic Population” where the first guideline for use  of fluoroquinolones in the athletic population is: “Athletes should avoid all use of fluoroquinolone antibiotics unless no alternative is available.” DON’T PRESCRIBE ATHLETES FLUOROQUINOLONES. It’s not that hard. In Dominick Cruz’s case, he was prescribed Cipro for a staph infection. There are a dozen other antibiotics that treat staph infections, and, according to this list, fluoroquinolones aren’t even the recommended treatment for staph infections. So why was Dominick Cruz given an antibiotic that has the effect of permanently weakening tendons and causing tendon ruptures? What an ignorant, foolish, awful doctor.

Even if the doctor who prescribed Cipro to Cruz wasn’t aware of the recommendations in “Musculoskeletal Complications of Fluoroquinolones: Guidelines and Precautions for Usage in the
Athletic Population,” he or she should have at least been aware of the black-box warning on Cipro which states, in the first sentence, “Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages.” It’s inexcusable for a doctor not to know about the black-box warnings on the drugs that they prescribe. And, assuming that he isn’t ignorant of the black-box warning, why is he prescribing a tendon-destroying drug to an athlete like Dominick Cruz??

In the podcast, it sounds like Dominick Cruz isn’t angry with the doctor who prescribed Cipro. He states, “it’s my own fault, not the doctors fault – I should have read the hazards of the antibiotic.” He’s obviously more generous than I am. Though generosity, even generosity toward those who hurt you, is a virtue, I don’t think he’s right. According to the Learned Intermediary Doctrine, pharmaceutical manufacturers have no obligation to inform the consumer/patient about the dangers of drugs. Dominick Cruz, as the consumer/patient, wasn’t even supposed to be told about the dangers of Cipro. However, his doctor, the “learned intermediary,” WAS supposed to know about the dangers of Cipro. His doctor should have known that it isn’t appropriate to prescribe a tendon-destroying drug to a UFC athlete, and he should have known that there are safer alternative antibiotics that treat staph infections. His doctor should have known better, and his doctor should be held responsible for making such a terrible prescribing decision.

As much as I respect how Dominick Cruz has come to terms with his injuries and found peace and surrender that helped him to recover (described throughout the video/podcast), fighting is what he does for a living, and I’m a little disappointed to hear that he’s not interested in fighting the system that poisoned him and destroyed his tendons. It is not his fault that his tendons were weakened by Cipro (and maybe other fluoroquinolones). It is the fault of the pharmaceutical companies that produce these dangerous drugs and the doctors that prescribe them inappropriately and flippantly. He shouldn’t have been prescribed Cipro for various reasons (staph should be treated with other antibiotics, he has a history of tendon injuries, and he’s an athlete) and the people who endangered him by giving him these drugs should be held accountable. Dominick Cruz probably has the clout to actually fight the people who poisoned him (unlike most of us, who struggle to gain justice for various reasons), and I hope that he does.

The tendon rupture that Dominick Cruz attributed to Cipro was his third tendon rupture, and earlier in the podcast you can listen to him describe his other tendon injuries (both of which he attributes to getting hurt while fighting, not weakened tendons from Cipro or any other fluoroquinolone). I wonder if he had taken Cipro, Levaquin, Avelox, Floxin, or one of the generic fluoroquinolones prior to his other tendon injuries. He thinks that the effects of fluoroquinolones on tendons only last six months, but, unfortunately, he’s wrong. Fluoroquinolone antibiotics can permanently alter the structure and strength of tendons. If he had taken a fluoroquinolone prior to his other tendon injuries, maybe they’re due to the drugs too, and he just hasn’t connected those injuries to the antibiotics. (Or, it’s entirely possible that those injuries were from fighting and training as he asserts.) A young, fit, well-conditioned, athlete like Cruz shouldn’t have weak, easily injured, tendons though. For his tendons to be so prone to injury, something is going on – maybe his tendons were weakened and changed by Cipro, Levaquin, Avelox, Floxin, or generic fluoroquinolones.

Since Dominick Cruz won back, and defended, his Bantamweight Champion title, it’s tempting to assert that he has fully recovered from his tendon injuries. However, if you listen to the whole podcast/video, Cruz goes on to describe how he now has debilitating plantar fasciitis. His tendons are messed up. His fascia is messed up. I certainly hope that he recovers from the plantar fasciitis, and I hope that he never has another tendon injury again. But I’m betting that he’ll battle tendon and fascia injuries for a while, and that the musculoskeletal destruction caused by fluoroquinolones will end his UFC fighting career. I hope I’m wrong about that.

Another thing that Dominick Cruz mentions in the podcast/video is that the UFC is in constant contact with injured fighters’ doctors. Why is the UFC allowing their fighters to be prescribed fluoroquinolone antibiotics???? Seriously, these drugs are dangerous, they can cause permanent disability, and there is a black box warning on them that notes that they can increase the risk of tendinitis and tendon ruptures. What is the UFC thinking allowing their fighters, the people who make them money, to be prescribed drugs that can injure, disable, and even kill them? There are hundreds of articles about the dangers of fluoroquinolones RIGHT HERE. They’re not difficult to access. It’s not difficult to see that fluoroquinolones are more dangerous than other antibiotics, especially to athletes who need to have properly-functioning tendons in order to do their job. Yet, the UFC is standing by, watching, while doctors prescribe tendon-destroying drugs to UFC stars–making them miss fights and costing both the athletes and the UFC massive amounts of money. It’s absurd. The UFC has the clout to stop this, and to tell their athletes, and the doctors that work with them, that fluoroquinolones shouldn’t be used on UFC athletes unless there are no viable alternatives. The adverse effects of fluoroquinolones are too severe, and the risk of injury after taking fluoroquinolones is too high, for UFC athletes to be taking these dangerous drugs.

I’m willing to bet that infections are rampant within the UFC, and that there are a lot of “floxed” UFC athletes. Open wounds occur often, mats and other equipment may be cleaned as well as possible, but they’re probably still swimming with nasty bacteria. It’s an environment with a lot of person-to-person contact, sweat, blood, and, inevitably, infections. If Dominick Cruz’s doctor threw Cipro at him to treat a staph infection, I bet the UFC doctors generally throw fluoroquinolones (Cipro, Levaquin, Avelox, Floxin, and their generic equivalents) at the UFC fighters whenever they get an infection. Fluoroquinolones are powerful, broad-spectrum, antibiotics. They’ll kill the bacteria. They’ll also ruin the tendons of the athlete, and cause disability in those who are unlucky.

Strong, athletic, young, capable, people can get hurt by fluoroquinolones. People like Dominick Cruz, who are at the peak of their fitness and athletic career, can experience weakened tendons, tanked testosterone, and worse, after taking fluoroquinolones. If the UFC thinks that their fighters are too strong to get hurt by these dangerous chemotherapeutic concoctions that destroy mitochondrial DNA, well, they’re wrong–and the athletes/fighters who are taking these drugs are being victimized by the willful ignorance of the doctors who prescribe these dangerous drugs.

I hope that all athletic organizations, coaches, sponsors, and athletes get together and put pressure on doctors to stop prescribing fluoroquinolone antibiotics to athletes. The dangerous and disabling effects of fluoroquinolones are well-documented, and there is no reason to prescribe them to athletes when there are other viable alternative antibiotics. Ruining an athlete’s career with a dangerous drug, when there are safer alternatives, is unacceptable. I hope that more people will wake up to the dangers of fluoroquinolones, and that fewer people generally, and specifically fewer athletes, are hurt by these drugs in the future.

flu tox get help you need banner click lisa

 

New Fluoroquinolones in the Pipeline

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

First-generation:

Second-generation:

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

Third-generation:

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

Fourth-generation:

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

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

Some of the fluoroquinolones in development include:

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

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

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

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

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

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

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

 

flu tox get help you need banner click lisa

 

fluoroquinolone-lawsuit-banner-trulaw

Children are Being Hurt By Fluoroquinolone Antibiotics

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

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

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

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

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

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

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

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

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

fluoroquinolone-lawsuit-banner-trulaw

 

flu tox get help you need banner click lisa

Publicizing Fluoroquinolone Warnings

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

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

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

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

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

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

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

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

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

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

AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient

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

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

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

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

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

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

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

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

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

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

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

SAFETY ANNOUNCEMENT

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

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

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

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

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

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

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

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

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

ADDITIONAL INFORMATION FOR PATIENTS

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

ADDITIONAL INFORMATION FOR HEALTH CARE PROFESSIONALS

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

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

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

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

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

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

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

    • Tendinitis/Tendon rupture

    • Muscle pain

    • Muscle weakness

    • Joint pain

    • Joint swelling

    • Peripheral Neuropathy

    • Serious Central nervous system effects include:

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

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

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

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

fluoroquinolone-lawsuit-banner-trulaw

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

BOX WARNING (revised)

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

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

WARNINGS AND PRECAUTIONS

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

ADVERSE REACTIONS

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

PATIENT COUNSELING INFORMATION

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

MEDICATION GUIDE

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

Tendon rupture or swelling of the tendon (tendinitis).

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

What is LEVAQUIN?

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

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

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

How should I take LEVAQUIN?

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

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

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

     

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

 

flu tox get help you need banner click lisa