Monthly Archives: June 2018

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 –

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

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. RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_fdcf314ce5-ccfc61e1a8-72144013 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.

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.


EMA Hearing on Fluoroquinolone Toxicity Part 1

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) held a hearing regarding the risks of permanent and disabling effects of fluoroquinolones (i.e. Fluoroquinolone Toxicity) on Wednesday June 13, 8018. More than 100 patient testimonials were submitted to the PRAC, and several dozen people who suffered from fluoroquinolone toxicity testified before the PRAC in-person.

The patients who testified were asked to answer three questions:

  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 optimize the safe use of quinolones and fluoroquinolones?

You can watch the hearing, and listen to the patient testimonials, through this video:

All of the patient testimonials were moving, thought-provoking, and insightful. Thank you to all who testified – many of whom traveled hundreds of miles/kilometers to get to the hearing. It is because of the people who testified (including those who testified in writing) that the PRAC now knows how truly devastating fluoroquinolones are. Hopefully they will be moved to action by the testimonials provided.

A transcript of the hearing will be published, and I will link to it when it is available. In the meantime, I will highlight some of the testimonials given during the hearing. I highly recommend that you watch the video, as the words directly from the victims’ mouths are much more powerful than my synopsis.

Elizabeth Carmouche testified that she was given ciprofloxacin as a prophylactic “in case” she got a urinary tract infection or travelers’ diarrhea while on holiday. She only took two of the prescribed pills, and has been suffering from the devastating effects of those pills for more than two years. She went from being an active to a woman with no pain, to suffering from severe joint, muscle, tendon, and bone pain, as well as peripheral neuropathy. She testified that doctors were unable to help her, and many dismissed the connection between ciprofloxacin and her ill health. She asserted that the following measures need to be taken:

  1. There needs to be official recognition of fluoroquinolone toxicity syndrome, and doctors need to be made fully aware of what the syndrome entails.
  2. Bayer, and the other pharma companies that produce fluoroquinolones, need to identify the precise mechanism of damage done by fluoroquinolones, and those companies need to establish a protocol for healing those who have been hurt by fluoroquinolones.
  3. Patients damaged by fluoroquinolones should be treated and guided by medical professionals.
  4. A red-flag system needs to be put in patient records so that those who have experienced an adverse reaction to a fluoroquinolone are never given fluoroquinolones again.

In closing, Elizabeth notes that fluoroquinolones are linked to mitochondrial damage, and that mitochondrial damage is linked to many diseases including Parkinson’s, Alzheimer’s, and other serious and severe diseases.

The next presenter was a pharmacist from Northern Spain named Manex Bettan Arguinzoniz (Bettan). He was just 37 years old when ciprofoxacin destroyed his body, mind, and health. He went from being athletic and able to play with his children, to being unable to do many of the activities that he loves. Despite being a pharmacist, he was unaware of the debilitating, disabling, and devastating effects of ciprofloxacin. He also found that his doctors and other specialists were unaware of the extent of the damage done by fluoroquinolones. His doctor (who is also his father in law) was only convinced of the link between Bettan’s health problems and ciprofloxacin when another doctor who had studied at the Mayo Clinic noted the reality of the link. Bettan suggests that fluoroquinolones be restricted so that they are only used in life-or-death situations in hospitals. He suggests that a stronger, possibly black-box, warning be added so that patients are aware of the dangers of fluoroquinolones.

One of the EMA PRAC members asked Bettan if he got his information about fluoroquinolone toxicity from patient testimonials or scientific papers. He answered that he read many papers about fluorouinolones. There are hundreds of research papers about fluoroquinolones and the damage they do listed on

The next presenter was Richard Cooknell. Richard was a firefighter before he was poisoned by quinolones. He is still unable to work, and suffers from many ill effects. He asserts that quinolones are used too widely, and that their use should be restricted to life-or-death situations. Richard points out that fluoroquinolones are often inappropriately prescribed for non-bacterial chronic prostatitis. He also points out that there is no information in the warning label about the effects of fluoroquinolones being permanently disabling, or that adverse reactions can be delayed. Richard was able to gain a diagnosis of fluoroquinolone toxicity by a rheumatologist, and he asked that fluoroquinolone toxicity be more officialy recognized and diagnosed by more doctors.

Richard points out that his prostatitis was non-bacterial, as many cases of prostatitis are, and that he never should have been given fluoroquinolones for a non-bacterial ailment. The post, “Cipro is no better than a PLACEBO at treating chronic prostatitis / chronic pelvic pain syndrome” goes over some information about this.

Richard also points out that NSAIDs and steroids have caused set-backs for him and many other victims of fluoroquinolones toxicity.

The next speaker was Markus Hamedinger. Markus suffers from tendon and joint pain, and has received a confirmed diagnosis of fluoroquinolone toxicity. Fluoroquinolone toxicity has severely affected Markus’s life, and he is unable to do many of the activities that he used to enjoy. His symptoms have not improved in the 2+ years that he has been sick.

Markus asserts that fluoroquinolones are used too often, and that they are inappropriately used when other, safer, antibiotics could be used. He notes the delayed adverse reactions to fluoroquinolones are a factor in keeping the effects of fluoroquinolones under-recognized. He says that doctors need to be made aware of exactly which infections need to be treated by fluoroquinolones, and which infections can be treated with other antibiotics. He also states that fluoroquinolone use should be banned in agriculture, to prevent exposure to fluoroquinolones from occurring through meat consumption.

The PRAC Chairwoman asked a question about repeated exposure making the reaction worse, and Markus noted that his reactions got worse and worse with each fluoquinolone exposure.

The next presenter was Miriam Knight. Miriam also presented on behalf of Raymond Miller and Geoffrey Robinson. Miriam is the co-founder of Quinolone Toxicity Support UK, and is also an administrator for Fluoroquinolone Toxicity Victims in Europe.

Miriam asserts that there is no role of quinolones/fluoroquinolones in the treatment of disease. She notes that mitochondrial DNA wasn’t known, studied, or acknowledged when quinolones were developed, and that they are chemotherapeutic agents.

Miriam points out that despite the official death toll from quinolones being low, there are many people who are hurt by these drugs in fatal ways – including aortic aneurysm.

Miriam notes the damage done by quinolones to mitochondrial DNA, and how mitochondrial DNA damage effects individuals differently depending on a variety of factors.

Miriam asserts, “There will never be a safe use of quinolones. They will always cause damage, observed or not.” And she also states that if removing them from the market is impossible, they should at least be severely restricted.

Miriam also asserts that quinolone toxicity should be a diagnosable illness with a diagnosis code. This is incredibly important in getting it acknowledged and quantifying the damage done by quinolones.

Miriam connects the dots between chronic pain, fibromyalgia, ME/CFS and fluoroquinolone toxicity.


There are several dozen other testimonials. In the interest of the attention-spans of those reading this, I am going to split my notes about the hearing into several posts. This is the first of __ (tbd) posts about the hearing.

THANK YOU to all who testified. The testimony provided is wonderful, thoughtful, passionately delivered, and those who provided it represented themselves and the “floxie” community wonderfully!

End note – To those who testified, if I misspelled your name, please let me know. Also, if anyone would like me to publish their testimony directly, please send it over. Thank you!