Editorial Note: The European Medicines’ Agency are holding a public meeting today about Fluoroquinolone antibiotics and the problems they can cause. They invited submissions. RxISK submitted. But was not selected for a presentation so we will not be there. Miriam Knight who has been a vigorous campaigner on the need to warn about the hazards of these drugs will be – see www.quintoxsupport.co.uk. Miriam has written this post.
One piece of advice for anyone being offered an antibiotic is to ask what is this – and then ask is it a fluoroquinolone. If it is and you have never had a fluoroquinolone before I would suggest saying you are allergic to all fluoroquinolones. The only times this might differ is if you have had one before without problems or if there is no other antibiotic left to take.
Don’t hold your breath but something may finally be done about Fluoroquinolone Antibiotics (FQs) in Europe. There are a few blogs on here about the devastating side effects including Flox-Tox; Guerilla Guide which talks about the FDA’s increases in black box warnings and their acceptance of the side affects as a syndrome, which they call FQAD. I can now report that the European equivalent to FDA, the European Medicines Agency (EMA) are going through the same motions.
The FDA announced in July 2016 that FluoroQuinolone Associated Disability (FQAD) was no longer a figment of anyone’s imagination and that the risks outweighed the benefits. They actually said “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.”(1). In both the USA and Europe there was much rejoicing in the Floxie community (‘Floxies’ are what people affected by Fluoroquinolones call themselves!). We actually thought this would have a big impact in the US which would then roll over to Europe. We were wrong.
From what I understand, just about nothing happened in the US. The FDA made a conscious decision NOT to pass on this information to every prescriber. Maybe they thought the increased package warnings would alert everyone and all the medical professionals would just stop using their favourite cure-all antibiotic, Cipro.
Nothing happened in the UK either. I wrote to our MHRA (Medicines and Healthcare products Regulatory Agency) and was told that they could only do something when the EMA told them to. Apparently they couldn’t possibly follow the USA’s lead anyway as there were “geographical differences”.
BUT something did happen in Germany! While I thought I had been busy building up my little group of 40 UK Floxies, they had built a forum of over 2,000 people who petitioned their own Medicines Agency (BfArM). I didn’t know it at the time but apparently any EU member state’s Agency has the right to call upon the EMA to investigate any drug if they think there is a reason. BfArM reacted to the petition by demanding a review of FQs and so the “review into systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects” was announced in early February 2017. (2).
You may have noticed it’s taken me over a year to bring you this news. I thought it was going to be a fairly quick procedure. It seems that the EMA were going to ask the FQ manufacturers a few questions and then give their verdict in July (2017). I thought we should get a little more organised and so our group compiled a report about FQ side effects – which, incidentally, we feel should more properly be called Adverse Reactions as they don’t stop once the drug is stopped. We put together 40 pages of information and sent them off to the EMA along with 40 stories from our members. We decided this was probably the kind of information they wouldn’t get from the manufacturers but that they really should have access to.
A few of us also arranged to pay a visit to our MHRA in London last May. I suppose we all laugh a little at our respective Health Agencies as we have to rely on them to regulate and licence the drugs that (supposedly) keep us alive while they rely on being funded by the pharmaceutical companies to keep them in business. The MHRA is no different since their Chief Executive used to be top man at GSK while I learned recently that the EMA gets 70% of its funding from the pharmaceutical industry.(3). The three representatives who met with us seemed to be genuinely interested in what we had to say about Floxing and the ongoing review – but we are still bearing in mind that their ultimate bosses are no doubt very comfortable in their relationship with Bayer and J&J.
So, the ongoing review? How is it going? Well, the result was originally to be announced in July 2017, but got pushed back to October, then November then February 2018. Meanwhile, in October a new paper was published by a Polish team that gave us new insights into how FQs affect the metabolism of every cell in many different ways – so we just had to send this off to the review team as well, which may have caused the next two delays! (4). To be honest, we found this paper really hard to understand so we took the liberty of producing our own easy-reading version which we put on our website (5).
We were still waiting for some kind of review announcement in February when one of our group noticed that the EMA had held it’s first ever public hearing – back in October! (6). We didn’t know that such a thing was possible but suddenly we decided that WE should have a public hearing too! We immediately started a campaign of emailing the two UK members of the review committee along with the Chair (also UK) and anyone else we could think of. By this time there were about 70 members in the UK group plus I’d also managed to become admin for the EU group – which represented Floxies from all over the EU. I asked for as many people as possible to email their country’s committee member (including the 2,000 Germans!). In less than two weeks we heard that the EMA were to hold their second-ever public hearing and it was to be concerned with – wait for it – FQ side effects!! (Although our friends at MHRA said they had pushed for a hearing as they felt our case was very strong, and they weren’t aware of any emailing campaign!).
Well, we may not take all the credit but I can announce that the EMA will hold a Public Hearing into the persistent and possibly permanent and damaging side effects of Quinolones and Fluoroquinolones on Wednesday, June 13th 2018 starting around 1pm. (7). It will be at the EMA’s headquarters in Canary Wharf, London (which apparently is purpose-built, huge and will be vacant when they relocate to Amsterdam after Brexit!). Applications to speak have now closed but any EU citizen can send in a written submission answering the following three questions:
If you want to write in, (only EU citizens, please!) the address is firstname.lastname@example.org.
I think that the first two questions can be answered by using your own Floxie experience as evidence. For the third question, it’s tempting to say to ban them when you’ve suffered agonising burning pain for years along with hundreds of other symptoms, but realistically this will never happen. It might be best to encourage them to impose a raft of restrictions that will force doctors to think very hard before they dare to prescribe them. This is something the FDA failed miserably to do and there has been no noticeable change in US prescribing habits since 2016. We want nothing less than a noticeable, dramatic change here in Europe – something that the FDA will just have to follow.
Apparently it was the ‘unusual’ amount of public interest that made the EMA decide to hold this Hearing. Hopefully, we can keep this level of public interest up so that they are flooded with written submissions to go along with the many speakers’ applications that they have received so far. This is us, the Floxies, doing something – I’m not holding my breath, but surely something will be done by our regulatory agencies in return?
6). http://journals.sagepub.com/doi/pdf/10.1177/0141076816663559 Review of first hearing.