QUINOLONE TOXICITY SUPPORT UK
Links and Resources
It's very important that you report your Adverse Reactions to MHRA (Medicines and Healthcare Products Regulatory Agency) via the Yellow Card Scheme. Your doctor or pharmacist should also be advised, and they may possibly send in a Yellow Card as well.
Go to this link and follow the easy instructions. It helps if you have the packaging with you as they ask for the batch number and dates the drugs were taken. If you feel you can't do this yourself, ask someone to do it for you. MHRA actively encourage patients to register any potential side effects from any drug and to update frequently if the effects continue. If no one reports anything they'll never know there's a problem!
You can also email MHRA directly for information about Quinolones such as updates to the Patient Information Leaflets (PILs), statistics of how many people have been affected etc. We believe it's important to keep reminding them about how dangerous these drugs are, so the more emails they receive the more notice they'll have to take.
Writing to your GP
With the help of a GP, we have produced a letter to show your doctor that your symptoms are not just in your head. It's deliberately short and gives very few references so he/she should manage to read it during an appointment! Just copy and paste into a document, add a date – and add your name if you want to, then print!
MHRA figures show Ciprofloxacin has seriously affected thousands of people in the UK.
Ciprofloxacin remains a popular drug of choice for GPs despite its very long list of possible side effects and the occasional news item about pain and tendon ruptures (1). Media stories may be ignored but a patient in your surgery with all-over excruciating pain, crushing headache, insomnia and psychiatric disturbance might pose a problem, especially if it's been a couple of weeks – or months – since the antibiotic was prescribed. The MHRA have stated that up to May 31st 2018 there have been 8819 ADR reports and 167 deaths linked to Ciprofloxacin and the other Quinolones since the Yellow Card system began. Since they acknowledge that only 10-15% of ADRs are ever reported, these figures could actually be nearer to 80,000 patients with severe problems and maybe 1400 deaths. Also, because Quinolone damage is considered “rare” while Quinolone Toxicity is not yet recognised in the UK, many sufferers are misdiagnosed with Fibromyalgia, CFS/ME or even psychiatric problems so the true number of affected patients might never be known.
The long list of side effects fails to warn that these Adverse Reactions can often be long-term disabling and even permanent (e.g. peripheral neuropathy). It's also never recognised that the toxicity is cumulative, with patients successfully taking one or more courses of these drugs until their tolerance threshold is reached (2). Studies show that the reactions rarely present as a single symptom and can appear in any combination at any time up to perhaps 12 months after cessation of the drug (3).
There are many academic papers regarding Quinolones and Fluoroquinolones, two of which were published by the BMJ in 2015: “Fluoroquinolone induced serious, persistent, multisymptom adverse effects”(3) and “Fluoroquinolones and collagen associated severe adverse events” (4). Another paper “Fluoroquinolone use and risk of aortic aneurysm and dissection” was recently published in the BMJ in March 2018 (5). The first paper to look at the myriad ways Quinolones create chaos at molecular level, as well as discussing possible treatments, is “Treatment of the Fluoroquinolone Associated Disability, the pathobiochemical implications”, published in Sept 2017 (6). Other studies focus on single aspects e.g. damage to Mitochondrial DNA(2, 6), crossing of the blood-brain barrier (7), or that Ciprofloxacin is no better than a placebo for most chronic prostatitis/CPPS (8, 9).
On the 10th July 2018, the FDA reinforced their earlier warnings from 26th July 2016 (10) about the permanent side effects by adding “fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects”(11). Following the FDA's lead and after public pressure, the European Medicines Agency is currently reviewing the “impact of long-lasting, disabling and potentially irreversible ADRs” to Quinolones and they considered this complex subject warranted a Public Hearing which was held on June 13th 2018 (12).
Quinolone Toxicity Support UK was founded in 2015 to help and provide information to sufferers in the UK and were honoured to be invited to speak at this Hearing.
Miriam Knight (March 2018)
Quinolone Toxicity Support UK
2. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2895369/?report=classic Mechanisms of Pathogenesis in Drug Hepatotoxicity Putting the Stress on Mitochondria. Jones et al. April 2010
3. http://casereports.bmj.com/content/2015/bcr-2015-209821.long (log-in required).
4. http://bmjopen.bmj.com/content/5/11/e010077.full Fluoroquinolones and collagen associated severe adverse events. Daneman et al. 2015
5. http://www.bmj.com/content/360/bmj.k678 Fluoroquinolone use and risk of aortic aneurysm and dissection. Pasternak et al. 2018
6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632915/ Treatment of the Fluoroquinolone Associated Disability. Michalak et al. 2017
7. http://cmr.asm.org/content/23/4/858.full Penetration of Drugs through the Blood-Cerebrospinal Fluid/Blood-Brain Barrier. R Nau et al. 2010
8. “Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Annals of Internal Medicine, 2004 Oct 19;141(8):581-9.9.
9. https://www.ncbi.nlm.nih.gov/pubmed/21334027 6-day intensive treatment protocol for refractory chronic prostatitis/chronic pelvic pain syndrome. Anderson et al. 2011
The European Medicines Agency (EMA) announced in February 2017 that they were starting a review of the “persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics”. This review is still ongoing (July 2018) but, as part of it, the EMA held a Public Hearing in June 2018 where patients/carers and health professionals from all over Europe came together to give evidence to the Committee (PRAC) undertaking the review.
A representative gave evidence on behalf of this group and several of our members also spoke as individuals, telling their own painful stories. We were happily surprised that many of the medical professional speakers also stated how serious – and dangerous – the side effects can be. The transcript of the statements and the video of the hearing (all five hours of it!) can be seen by clicking the links below – individual statements can be seen by clicking on 'show more' and then the speaker's name.
Transcript of evidence: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/06/WC500250807.pdf
We have also submitted a full report about Quinolone Toxicity to the review Committee along with several updates as new information becomes available. Many members have written independently to the Committee with their own experiences and we encourage new sufferers to also submit their stories – we firmly believe they can't know how bad it is if no one tells them.
MHRA and the FDA
These links are to past MHRA Drug Safety Updates (DSUs) followed by the US Food and Drug Administration (FDA) alerts to show just how far behind we are with regard to warnings about Quinolones.
http://webarchive.nationalarchives.gov.uk/20090511015115/http://mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON023077&RevisionSelectionMethod=LatestReleased (from 2008 re Moxifloxacin - page 8)
The latest FDA Update concerning Quinolones was issued on July 26th 2016.
or the full pdf can be read here – but it's 69 pages long!
The main points here are taken from the summary in the press announcement:
“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.”
“...fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.”
“Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis and uncomplicated urinary tract infections, the FDA has determined that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options. For some serious bacterial infections, including anthrax, plague and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option.”
As I write this the 2016 US Presidential Race between Hillary Clinton and Donald Trump is picking up speed. Two days ago (14th Sept 2016) it was revealed that Mrs Clinton had just been prescribed a 10 day course of Levoquin (Levofloxacin) for mild pneumonia.
(http://www.usatoday.com). This is one of the illnesses the FDA just said it shouldn't be used for!
http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm This update from the FDA was issued on the 12th May 2016 as a pre-cursor to the July announcement, and says much the same. It comprehensively covers ALL Quinolone antibiotics and states:
“The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.”
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM365078.pdf This one from August 2013 required ALL Quinolone packaging (except eye and ear drops) to carry warnings of the “serious side effect of of peripheral neuropathy” which may become permanent.
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126085.htm The FDA issued this alert in July 2008 advising manufacturers of Quinolones to add a Boxed Warning (known as a Black Box) to highlight the dangers of the increased risk of developing tendinitis and tendon rupture with taking these drugs.
The British Medical Journal is one of the World's oldest yet highest-ranking medical journals so we were delighted when they published two papers about Quinolones in September 2015.
http://bmjopen.bmj.com/content/5/11/e010077.full.pdf which concludes that Quinolones are associated with subsequent tendon ruptures and may also contribute to aortic aneurysms.
http://www.myquinstory.info/wp-content/uploads/2015/10/FQ-induced-serious-persistent-multisx-adverse-effects-BMJ-Case-Reports.pdf which demonstrates that Quinolones cause persistent multisymptom Adverse Effects
http://www.bmj.com/content/bmj/324/7349/1306.full.pdf this third paper was published in 2002 and demonstrates a link between Quinolones and tendinitis, especially in those over 60. An increased risk was seen if corticosteroids were taken at the same time
http://natajournals.org/doi/pdf/10.4085/1062-6050-49.2.09 This is a useful paper published in the Journal of Athletic Training in June 2014, which outlines the dangers of applying normal sports injury techniques to Quinolone damaged tendons.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175508/pdf/bcp0072-0381.pdf The British Journal of Clinical Pharmocology published this article in 2011, describing the neurotoxic effects of the different groups of antibiotics. Scroll down 4 pages to see Table 2, and Quinolones are discussed at the bottom of that page.
Daily Mail Articles
The Daily Mail have featured Quinolones quite a few times over the years, the first article being published in May 2016 after we contacted them!
http://www.dailymail.co.uk/health/article-5983853/Why-doctors-doling-antibiotics-left-thousands-crippling-pain.html published in the Daily Mail July 2018.
https://www.nature.com/articles/d41586-018-03267-5 published in Nature Magazine 2018
http://www.theecologist.org/News/news_analysis/897407/popular_antibiotic_ciprofloxacin_linked_to_uk_deaths.html published in 2011 – nothing's changed.
http://www.theguardian.com/commentisfree/2012/jul/10/growing-menace-adverse-drug-reactions 2012 - the journalist himself had a brief episode of being floxed.
http://www.iflscience.com/health-and-medicine/just-one-antibiotic-treatment-can-alter-your-gut-microbiome-months/ published in November 2015, this paper shows how antibiotics disrupt your gut – for up to 12 months in the case of Ciprofloxacin! For the less colourful but full academic paper go to http://mbio.asm.org/content/6/6/e01693-15.full
Published as 'New Cipro, Same Side Effects' in the Washington Post December 2002, this article discusses the introduction of Cipro XL, the one a day tablet. It also usefully mentions the 2000 postal workers from North East Washington who were put on a 60 day course of Cipro after 2 colleagues died from anthrax exposure the previous year.
Another Washington Post story, and very informative.
One of our members is bravely writing a blog about his life, his symptoms and his ups and downs. You may like to read it to see what happens, to sympathise, or to just say you never knew!
There are links to over 200 academic papers and media articles on the Floxie Hope website at https://floxiehope.com/ plus many articles written by Lisa Bloomquist herself.
Art by Debbie Carol