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:
- What is your view on the role of quinolones and fluoroquinolones in the treatment of infections?
- What is your view of the risks associated with quinolone and fluoroquinolone use?
- 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:
- There needs to be official recognition of fluoroquinolone toxicity syndrome, and doctors need to be made fully aware of what the syndrome entails.
- 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.
- Patients damaged by fluoroquinolones should be treated and guided by medical professionals.
- 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 https://floxiehope.com/fluoroquinolones-links-resources/.
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!