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
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
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.
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.
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!