EMA Decision on Fluoroquinolones – Next Steps

The EMA (European Medicines Agency) review of fluoroquinolones is ongoing, and your input is requested/needed.

On June 13, 2018, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) heard testimony from Europeans who suffered from fluoroquinolone toxicity, and on May 10, 2018, the PRAC issued their recommendations. (You can read and view the patient/victim testimonials HERE, HERE, and HERE, and you can read the PRAC’s recommendations HERE.) The next step is for the Committee for Medicinal Products for Human Use (CHMP) to consider the recommendations of the the PRAC on the safety of medicines on the market and recommend changes to the EMA. The CHMP will recommend changes in the marketing of fluoroquinolones, or may even recommend suspension or withdrawal of fluoroquinolones from the market. You can read more about the role of the CHMP HERE.

I would like to encourage everyone who has been hurt by fluoroquinolones to contact the CHMP so that they can take your testimonials and information into consideration when making their decisions and recommendations. Contact information for the CHMP members can be found HERE. I recommend that you send an email with a brief version of your personal story, along with information and references from the articles about fluoroquinolone toxicity that can be found in the “research” section of the Links & Resources page on this site or elsewhere on the internet to both the CHMP Chair (Harald Enzmann) and the Vice-Chair (Bruno Sepodes) I plan to send a letter that contains a combination of the information in the post, “What is Fluoroquinolone Toxicity” and the information that is found in the ebook, Hacking Fluoroquinolones (I’ll post my letter once I write it). You are welcome to use anything I (Lisa Bloomquist) have written on this site, or in my guest-posts on other sites, in your letters to the CHMP.

The CHMP meeting starts on November 12, 2018, and it is recommended that you send your emails to the Chair and Vice-chair of the CHMP as soon as possible.

Miriam Knight, a fluoroquinolone toxicity victim advocate, co-founder of Quinolone Toxicity Support UK, and an administrator for Fluoroquinolone Toxicity Victims in Europe, has written the following letter, and you are welcome to use it as a template. 

Dear Chair, Vice-chair and other members of the Committee for Medicinal Products for Human Use,

We in Europe wish to express our strong concerns regarding the recent recommendations made by the PRAC following their lengthy review into the side effects of Quinolones and Fluoroquinolones. We understand that the recommendations have now been passed to the CHMP for your opinion. We are very disappointed in the findings so far.

Representatives of this group and also individual members from across the EU were invited to speak at PRAC’s Public Hearing in June. From the EMA website we understand that “Contributions at public hearings inform the committee’s decision-making”. Even after taking part in the teleconference last week we are unable to find any evidence in the recommendations that our written and spoken interventions have in any way been used to inform the PRAC’s decision making.

Our main concern is that the evidence which we and others have provided regarding the damage Fluoroquinolones cause to human mitochondrial DNA (MtDNA) has been totally ignored. This evidence has been in the public domain since 1993 (1,2,3), yet is not mentioned in any of the license applications, SmPCs or PILs. Both the summary of the Public Hearing and the recommendations from the review fail to mention it, despite the overwhelming evidence. We despair that the Agency charged with safeguarding Public Health cannot see the huge danger in licensing products that physically damage humans. We hope that the CHMP and the Pharmacogenomic Working Party will at least understand the implications of this mechanism of action and will take the time to study ALL of the available evidence.

The Medical Profession seem to have a problem understanding how and why the Fluoroquinolone class of antibiotics have such wide ranging effects on some patients, indeed most are unable or do not believe patients when they are told of these side effects even with written and recorded evidence (4). It is clearly within the remit of the Pharmacogenomics Working Party to provide advice to the CHMP on general and product-specific matters relating to pharmacogenomics, although perhaps this aspect of the review was beyond the scope of the PRAC.

Not only do Fluoroquinolones have an effect on MtDNA but they also disrupt the metabolic processes of both our mitochondria (e.g. the TCA cycle) and also our cells (5,6). Again, the evidence for this has been glossed over by the PRAC’s recommendations, despite the many testimonies at the Public Hearing attempting to convey the sheer agonising horror inflicted by these drugs.

We understand from the teleconference that the recommendations passed over to the CHMP are more detailed than the brief version that was published prior to the teleconference. We sincerely hope this is so as all we have seen so far is a tenuous nod towards implementing changes with a view to protecting the public. The biggest risk to human health from the Fluoroquinolones is the damage and destruction caused to every cell (6) – which can potentially lead to multisystem problems including organ failure and cancers (4), and which surely outweigh the benefits. The mitochondrial damage also has implications on second generations – something which has yet to be studied. We notice that the PRAC dropped their original proposal to encourage further studies and research to be undertaken with no explanation. We find this decision, along with all of PRAC’s expressed concerns, to be disingenuous, at the least, at most we find it dangerous to future victims as well as present victims.

We cannot urge strongly enough that you fully and properly review all the evidence showing the catastrophic effect Fluoroquinolones can have both physically and mentally (4). A full understanding of why some people are affected immediately while others can tolerate several courses needs to be taught throughout the medical profession. It is simply not good enough to say these effects are “very rare” when it is well known that many people, after experiencing nothing from a first course go on to be affected by a second or third course. Others seem to tolerate repeated courses before just one more tablet sets off a serious reaction. The variety of personal thresholds is believed to depend on the individual’s mitochondrial condition, including either congenital deficiencies or acquired insults.The reality is that if someone takes enough Fluoroquinolones, they will eventually be affected: this cannot be defined as “very rare”. The true figure is unknown and until extensive research is undertaken it will remain unknown.

It is also not good enough to say these effects are “very rare” when it is well known that neither doctors nor patients associate an ADR that occurs weeks or months after cessation of the Fluoroquinolone with that particular drug – yet this is precisely what happens. There are possibly thousands of people who have been affected yet never know; their symptoms often labelled as Fibromyalgia or CFS/ME (which, ironically, have no known cause) or even MS.  Many times we have heard of e.g. eye specialists saying they have prescribed Fluoroquinolones hundreds of times yet no one has reported any problems: why would a patient with sudden muscle or tendon problems go back to their eye specialist? More patients have been seriously affected by Fluoroquinolones than anyone can imagine.

All Medical Professionals, member state Health Agencies and ALL committees working within the EMA have to fully understand the human catastrophe caused by this unique class of drugs (not exactly antibiotics as they have also been used as chemotherapy agents). Until the naïve ‘one size fits all’ approach to medicine is overturned – and this is obviously where the Pharmacogenomics Working Party is essential – innocent patients will continue to be harmed by the innocent doctors who are trying to do no harm.

References*:

1). Acridones and quinolones as inhibitors of ubiquinone functions in the mitochondrial respiratory chain. July 1993 Walter Oettmeier et al
https://pdfs.semanticscholar. org/a9fd/ 33039c3d987093746db40fbd8d7782 f3b078.pdf
2). Delayed cytotoxicity and cleavage of mitochondrial DNA in ciprofloxacin-treated mammalian cells. Nov 1996 Lawrence JW et al.
https://www.ncbi.nlm.nih.gov/ pubmed/8913349
3). Ciprofloxacin impairs mitochondrial DNA replication initiation through inhibition of Topoisomerase 2 August 2018 Hangas et al
https://academic.oup.com/nar/ article/46/18/9625/5088042? fbclid= IwAR0Xu4wIXprB3wF6nBP2EZxWinNm mVvUvjIQ8GPHPaLS81KsxE_ ucJZ99K8
4). Fluoroquinolone-induced serious, persistent, multisymptom adverse effects.
Oct 2015. Golomb B. et al
http://casereports.bmj.com/ content/2015/bcr-2015-209821. full
“…with progression that continued following discontinuation evolving to a severe, disabling multisymptom profile variably involving tendinopathy,muscle weakness, peripheral neuropathy, autonomic dysfunction, sleep disorder, cognitive dysfunction and psychiatric disturbance..”
5). Exploiting bacterial DNA gyrase as a drug target: current state and perspectives
Nov 2011 Frédéric Collin et al.
https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3189412/
6).Treatment of the Fluoroquinolone Associated Disability – the pathobiochemical implications
Nov 2017. Michalak K. et al .
https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC5632915/

* These few references have been chosen as the most relevant to this letter.  The PRAC tell us they studied over 400 papers before reaching their decision but have not yet told us which 400.  As all scientists know, it is possible to reach any conclusion you like depending on which papers you quote. There are many more than 400 papers available which show the harm that can be caused by Fluoroquinolones.  Perhaps the best way to judge the danger is to work with the actual sufferers (we are either sufferers or carers ourselves) – as Dr Golomb (4) has done.

Thank you, Miriam, for all your advocacy work with the EMA (including the PRAC and CHMP)! And thank you to all who reach out to the CHMP – your advocacy work is appreciated too!

The PRAC recommendations were disappointing for many fluoroquinolone victims and advocates. Hopefully the CHMP recommendations will be stronger and more protective of patients.

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3 thoughts on “EMA Decision on Fluoroquinolones – Next Steps

  1. Barbara November 7, 2018 at 8:13 am Reply

    They are in the process of discussing them today and tomorrow, so if you want to email best do it now.

  2. L November 7, 2018 at 11:30 am Reply

    Yes, thank you Miriam! The one sentence I would have liked to have corrected is this: “There are possibly thousands of people who have been affected yet never know…” Should have made that MILLIONS, using Dr. Charles Bennett’s own figures. If we already know that millions have been injured, think of all the people she mentioned who have been misdiagnosed with fibromyalgia, Epstein-Barr, MS, lupus, chronic fatigue…or just told it’s old age, or all in their head. Sadly, the EMA seems no better than the FDA when it comes to choosing between patient and big pharma.

    • Barbara Arnold November 7, 2018 at 11:26 pm Reply

      L I said hundreds of thousands. I used Miriams letter as a template, so added a few things. You can to if you wish. Miriam has said, do what you like with the letter. Just send an email even if its only a few words of your own.

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