Fluoroquinolones: Not so Carte-Blanche
Last June, in “Historic Summit: Flox and Tox Get Together”, I told you about the European Medicines Agency’s Review and Public Hearing into the side effects of Fluoroquinolones.
It was only the second time in the EMA’s history that they’d decided to hold a Public Hearing (because of the amount of public interest in this review) (1), so it was indeed historic. They later said to their stakeholders that the process of holding Hearings would “ lead to better safety recommendations; in line with real needs of patients and healthcare professionals as identified during hearings”(2). Please remember that quote.
The review finally came to a halt in October when the committee who did all the work (PRAC) handed over their recommendations to another committee (CHMP) to see if they agreed – which they did. The recommendations are now waiting for the European Commission to rubber stamp them and they will then become law.
If I tell you that I am quoted in a Scottish Newspaper as saying “The recommendations don’t really amount to much more than what the warning leaflets say already,” I think you might get an idea of just how far-reaching these new recommendations aren’t (3). I wrote to the PRAC committee with a blow by blow rebuttal of their proposals and finished it with “I find nothing in these recommendations that could not have been produced in February 2017” – that’s when the Review was started.
As a quick reminder of what exactly we’re talking about here, the Fluoroquinolones (FQs) are a unique class of synthetic antibiotics, the most popular of which is Ciprofloxacin (Cipro). Its siblings are Levofloxacin (Levaquin), Moxifloxacin (Avelox) and Ofloxacin (Floxin) and there are many other generic names so always check for the class – Fluoroquinolone. They’re unique because their mechanism of action targets bacterial DNA to prevent bacteria from replicating.
The clever people who developed FQs in the 1960s knew they didn’t affect our cellular DNA and possibly weren’t aware that we also had mitochondrial DNA (MtDNA – discovered in the 1960s). However, certainly by the early 1990s when the first Cipro licence was sought, there was academic evidence that mammalian MtDNA was damaged along with bacterial DNA as they happen to share a couple of enzymes (apparently from when everything was floundering in the Primaeval Soup) (4). I can find no reference to this significant problem in later licence applications (e.g. 2010) nor in the latest versions of the package leaflets (2019 – available on line). We’re human, so MtDNA is very important to us; our mitochondria are generally referred to as the powerhouses of our cells and if their DNA is damaged so are we.
In addition, the FQs also affect the way each of our cells goes about its business. I’m not that good at biochemistry but there are some amazing processes that happen during the metabolism of our cells and it seems that FQs mess up just about every single process (5,6). In other blogs (The Myth of the Magic Bullet and Guerilla Guide.) you can read about the devastating chaos that can happen when someone is floxed. Doctors always shake their heads in disbelief when sufferers of FQ Toxicity (Floxies) present with a huge variety of seemingly unrelated symptoms yet, if they would consider that every organ, every system, every part of the body has been affected they would understand. Not that they would be able to help, of course, as the only cure for this illness caused by their drugs is rest. That’s it. There is no cure.
All this was stated in different ways at the Public Hearing. Some very sick people dragged themselves across Europe to address the Committee and many others wanted to but were not selected. These sufferers desperately wanted to take the opportunity to tell the members of the PRAC how they were previously fit and healthy, apart from maybe a UTI or prostatitis pain. They then took this antibiotic, prescribed by a trusted doctor, and it literally stole their normal lives. They were left with an agonising physical and mental hell: I’m not being a drama queen here, simply telling the truth.
Only thirteen sufferers were selected to speak because of time constraints, along with eight professional speakers including a Bayer representative. Apparently, the PRAC also took into consideration many written testimonials presented by support groups like ours from several European countries and evidence from the manufacturers themselves. We were later told that over 400 academic papers had been studied before the recommendations were made, which interests me, and I have asked for the list of these papers. I’m interested because I have no idea if they have seen any of the papers I used when writing our group’s report. For example, I quoted from the 1996 paper (4) which demonstrated how Fluoroquinolones damage mammalian mitochondria, and also a 2017 paper (5,6), which explains at length how FQs create havoc in all mammalian cells by interfering with the many different metabolic processes and causing oxidative stress. The recommendations seem to make it clear that neither these papers were considered.
Most doctors don’t understand why the symptoms are so varied with muscle and joint pains, gut problems, insomnia and panic attacks, tingling or burning skin, agonising nerve pains, insomnia, hallucinations and anxiety. Most doctors have no idea that sometimes these effects don’t start for weeks or months after the pills have been taken. Most doctors see a Fluoroquinolone as a marvellous cure-all; if in doubt – Cipro will sort it out. I could almost accuse some doctors of being extremely lazy; rather than send a sample off to be cultured isn’t it quicker to just prescribe Cipro as it will kill anything?
One other thing about FQ Toxicity is that the majority of patients will take a course of it and think nothing of it. They may take two or three courses and I’ve even heard of someone taking around fifty courses for a chronic problem. I get to hear about these people as they write for help after finding themselves in pain, with a torn tendon perhaps, or one of the other myriad symptoms. Why some can tolerate so much while others are flattened by just one tablet is not really a mystery when you consider our differences in genetic make-up and research is being carried out at the moment to try to find the ‘key’. We already know that FQs (and certain other drugs that affect mitochondria) should not be given to people with various genetic deficiencies, one big problem being that often people are unaware of a deficiency until they take an FQ! To us, it’s more a case of not IF someone will be affected but WHEN.
I naively hoped that putting all our evidence in front of the PRAC would do the job. I also helpfully pointed out that the original licence applications had not mentioned mitochondria and oxidative stress and nor had subsequent applications. Nothing I have seen or heard from the EMA has made me think that they have in any way acknowledged this information. And yet they must know, the evidence is there, so surely they know that these drugs are causing serious, life threatening problems in what were healthy individuals with only a simple or suspected infection?
No? OK, so we have more work to do. A lot more work. The new recommendations will hopefully restrict most of the FQ prescribing for simple infections. Although this was reduced anyway in the UK thanks to the antimicrobial stewardship scheme, apparently FQs are extremely popular in many other European countries with Greece winning the top prize, so they will see the most benefit. The recommendations also said that the Quinolone-only drugs, which are the early versions from before a fluorine molecule was added to make them really potent (and which made them Fluoroquinolones), would be withdrawn from the market. This, again, is more of a big deal for other countries as these older drugs were already withdrawn or simply just not used in the UK.
One point we’re really upset about is that the Committee don’t seem to have paid much attention to all the testimonies from men saying they were seriously affected after being given Cipro for suspected prostatitis (7). Cipro and its sibling Ofloxacin are the recommended antibiotics for prostatitis and the present UK guidelines say to prescribe either for 4 to 6 weeks. No mention is made of waiting for culture to check for actual infection, and lower down the page there is a statement that actually says a meta-analysis found that “antibiotics were no more effective than placebo for treating CP/CPPS (Chronic Prostatitis/Chronic Pelvic Pain Syndrome) (8). The recently published recommended changes to the Product summaries for doctors (SmPCs) and the patient leaflets (PILs) have no changes listed for Cipro’s use with prostatitis and only a simplified list for Ofloxacin – with no mention of suspected prostatitis. To all the men who have had their lives ruined by these drugs I can only say I’m sorry, we’ll try harder…
If you want to look at these recommended changes you can find them on the EMA link below (1), just above the blue banner that says ‘key facts’ (it’s a pdf with ‘article 31’ in the title). One thing I will admit they are trying to make clear is the warnings on the patient leaflets. Apparently the EMA expect that a patient should read these warnings and then discuss with their doctor about the suitability of this antibiotic for their condition. Between them they are supposed to make a risk/benefit assessment before deciding whether to use a FQ. My experience of a UK doctor’s ten-minute appointment is that a discussion will rarely happen although this expectation cleverly shifts any ensuing blame directly onto the patient who has been adequately warned (they should have read the leaflet!). Perhaps in the make-believe world of the European Commission this all makes sense. Whether it will actually meet the “real needs of patients and healthcare professionals as identified during hearings” remains to be seen: I, and many others, very much doubt it.
1). EMA Public Hearing page; scroll down for agenda and list of speakers/ text of written interventions and the summary report (available in several languages). Scroll further for the video of the Public Hearing (4 hours!).
Editorial Note: Post by Miriam Knight
4). https://www.ncbi.nlm.nih.gov/pubmed/8913349 (but abstract only available)
5). Treatment of the Fluoroquinolone-Associated Disability: The Pathobiochemical Implications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5632915/
6) .http://www.quintoxsupport.co.uk/our-version-of-a-2017-academic-paper.html
7). https://cks.nice.org.uk/prostatitis-chronic#!scenario
8). [https://www.ncbi.nlm.nih.gov/pubmed/22870266 Cohen et al, 2012].
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So again the drug companies have acted as if they will do something about this serious issue affecting 100,000s of people, possibly millions, but in actual fact they have done nothing that will bring about any real change that could bring about help and recognition for these poor people.
Nicely deflected and any real action averted, so they can continue prescribing en masse, and continue making lots of profit.
Greed before people’s lives and health, yet again.
“We comply with the requirements of our regulatory authorities”.
They love to bring this one out, making them sound reasonable and responsible to the uninformed. They always forget to mention the regulators are in their pockets with ex drug company employees running the MHRA, and MHRA staff having shares in the drug companies.
“Think of the millions that have been helped by these drugs”. Another favourite deflection technique used by drug companies. But what about the millions harmed. And I would very much like to see evidence that “millions” are saved by these drugs. In serious life threatening bacterial infections some might be saved, but I doubt very much it is on the scale they mention. As has been established, most of the prescriptions for these drugs are not written for the serious life threatening infections they are intended for.
“Laughed at, ridiculed, told it was in their imagination”. Typical response when you try to get help after being harmed by prescription drugs. It’s all you. And that’s only the ridicule you experience from the doctors. I have known of whole families ostracizing a person left damaged from prescription drugs, because they either can’t or refuse to believe what is happening to them. I have experienced this to some extent with my own family.
This is a quick P.S. to my blog above. I forwarded the video link as an afterthought but I didn’t mention it in the blog as the programme was being aired around the same time as I was writing.
A member of our group was visiting her friends and relations in South Africa over Christmas and she happened to get talking to someone who knew someone. The conversation turned to health (as always) and our friend spoke of the terrible time she’d had after being floxed. Her acquaintance turned out to work for a TV news programme and his editor had just been severely floxed. The programme was CarteBlanche, renowned for its investigative journalism, and the result of this meeting is in the 20 minute video above.
What I find most interesting is that the South African manufacturers of fluoroquinolones have already sent out letters advising health care professionals about new restrictions following the EMA decision in Europe. Have the UK manufacturers or even the MHRA sent out similar? Not yet!
Interestingly heard of the Carte Blanche TV show today at work. Was prescribed Ciprobay for suspected prostatitis – after about 5 days of using the drug I contacted the urologists’ office about the joint pain, nausea and general malaise I was experiencing and was told to stop use.
The joint pain in general has gone, but I’ve still got some quite specific pains which I’m now hoping to hell will soon pass.
Fingers crossed I’m not in that small group of people who suffer lifelong negative effects from this drug.
I have read and followed these events with great interest and would have liked to have given evidence first hand of the effects and experiences caused by this class of drugs unfortunately that is difficult when layed up virtually 24/7 with multiple and progressive bodily issues ongoing. First as so badly affected over a period of 22 years and having reported symptoms from the very outset that should have prevented at the very least being given them again or at worst given again in the situations and with contraindicated medications as to nearly kill a person and may yet given damage caused. If I had been so flippant, ignorant, dishonest, and downright incompetent In my own profession after having the number of warnings and chances of ensuring someone’s safety where prevention had plenty opportunity we would be looking at another Piper Alpha or Deep-water Horizon disaster. Basically at a scale of disaster that notice would be taken how serious. I had already witnessed first hand how cheap life is in some cases in industry I was involved in, but it has learned from its lessens to a greater extent over the similar time these drugs been available. As I write this from my bed, I could write a best seller of the medical gas lighting, lies, collusion, cover up and back it up with evidence of reportings, advice given to keep symptoms tucked away for a rainy day! Meaning for insurances. I lie here thinking of the lives wasted, my own included, I worry about the future the way I and others treated with this, a recent Gp comment after a 30+ week wait for certain tests. Quote! You won’t get any help from us or from NHS with this. So! You will just treat any additional symptoms that may arise out of the vast damage it’s caused and creating ? Like cancer, stroke, heart attack, peripheral artery disease, mast cell reactions, histamine reactions, central and autonomic nervous system issues, skin, orthopedic, asthma, the list goes on. A real chimera. Oh yes, I have considered the low cost , high profit worldwide prescribing and possible savings as well as imperial prescribing. I have considered the fact that many many drug reactions are not logged or reported for various reasons. But not to point someone has had serious injury and life threatening damage where the possibility of further damage could be prevented. I have considered the litigation aspect to and know full well a high profile action of thing I could prove may bring a great deal of unwanted media attention. I don’t doubt the powers that be have looked at this and deemed that’s enough needed. But consider this, if it was you, your husband, wife, son, daughter , grandchild, how would you feel knowing you could have done more. I realize doctors deal in death and injury, disability, illness and chancers form part of the package. But not just my life was ruined needlessly, it’s a whole family that has had to experience the effects of these drugs that unless fully experienced could not be invisaged. To then add the cover up to necessary help for damage left takes the matter beyond criminal!
Floroquinonoes like cipro,floxin . avelox, etc.are first biochemical poisons based on a chemo drug from the 1960s.never take unless severe lung o r oblem then dr. Must warn you. Permanent severe tendon and nerve damage. I’ve bee n disabled 25 years so far. Life’s wasted. I’m artist and writer. Lost success drug Co iwes me big never pay. No justice.
Carte Blanche, a very informative film..
Thank you for warning us..
https://www.dailymail.co.uk/health/article-5983853/Why-doctors-doling-antibiotics-left-thousands-crippling-pain.html
We have our ‘Carte Blanche’ in the UK..
Introducing:
We Must Look After Our Antibiotics – Trust your Doctor..
Pinned Tweet
Prof Sally Davies
@CMO_England
·
25 Oct 2017
It is essential we #keepantibioticsworking – everyone has a role to play. It’s really important to trust your doctor
https://www.youtube.com/watch?v=y1NV9ueDGpk&feature=youtu.be
Fluoroquinolones: An FDA advisory panel urge drug …
https://medium.com/the-intrepid-fascinator/fluoroquinolones-an…
A spokesperson for the MHRA said: “Ciprofloxacin and other fluoroquinolones are acceptably safe and effective medicines to treat a range of infections. The potential risks are clearly described …
https://medium.com/the-intrepid-fascinator/fluoroquinolones-an-advisory-fda-panel-urge-drug-companies-for-clearer-and-prominent-label-1c6a2980fe5f
Amongst those known to have been affected by the drug include Dick Decent, keyboardist of the rock group Def Leppard, who in September 2012 wrote in his suicide note: “I didn’t kill myself, Bayer killed me.”
The “Intrepid-fascinator piece was written 3 years ago and not so much has changed today except MHRA are talking to our group and we’ve been invited to two meetings with them. Other changes are that Rob Oldfield’s suffering ended in 2016 when he died from ‘heart problems’ (although I think he could probably have said the same as Dick Decent) while Jane Allen is still living with pain every day; sometimes new pains, sometimes agonising pains but always pain.
To think that some Health Professionals act stupor when all this damage happens to their patients, due to the meds they prescribe, is beyond my comprehension.
When caring loved ones question what is going on, due to erratic prescribing, they consider you ‘crazy!’
Sadly, it seems, that all involved have a ‘Carte-Blanche’ to commit heinous crimes against their patients.
Where are the regulatory bodies, to remedy a problem that has gone way out of control? ~ Nowhere to be seen!
These are crimes against humanity and I cannot wait for the day when all involved are held accountable.
How can anyone possibly speak up for anyone being mistreated with meds, if you know the consequences are dire? ~ No one seems to care or they tell you it is all inconsequential!
How can one possibly do more, Martyn if the one who speaks up are held at ‘gunpoint!’
“However, certainly by the early 1990’s, when the first Cipro license was sought, there was academic evidence that mammalian mitochondrial DNA
(mtDNA) was damaged along with bacterial dna”.
Most classes of psychotropic drugs, and “mood stabilisers “ eg Valproate
Have been reported to cause damage to mtDNA.
These intra-cellular, but extra-nuclear “energy powerhouses “ may be vulnerable to drug induced damage by their location as membranated organelles within the cytoplasm.
The cardinal “clues” to mtDNA damage are altered liver enzymes (many other causes) and drug induced LACTIC ACIDOSIS.
If a medication causes the latter, this is reported as likely due to mtDNA damage.
Might therefore idiosyncratic vulnerability to mitochondrial toxicity be the basic common denominator behind the intense, multi-systems, devastating ADRs caused by antipsychotics, antidepressants et al ?
I don’t know, but it has been suggested that the first steps to prevent mitochondrial damage should be
“during drug development “.
Thank you bring the disabiling effects fluoroquinolones cause. I too was floxed with Ciprofloxacin 7 years ago it has affected me from head to toe my life will never be the same, I wish I was warned what these drugs can do!
Be aware of these insidious drugs. They cause delayed adverse reactions. They don’t always cause immediate reactions, like while on the drugs! Be aware that the Fluoroquinolones are given without your knowledge or permission.
12 years ago I was given IV Levaquin as a prophylactic during minor surgery. I HAD NO INFECTION! Within a few months my body started to fall apart and I have not recovered.
For me damage was permanent!
Team 10 Investigates: San Diegans describe popular antibiotic causing devastating side effects
Posted: 3:54 PM, Sep 20, 2019
Updated: 2:25 AM, Sep 21, 2019
SAN DIEGO, Calif. (KGTV) – It’s one of the most widely prescribed antibiotics in the country. It’s called Cipro and the side effects could lead to your death. Experts are now calling for tighter controls on these prescriptions to protect the public.
https://www.10news.com/news/team-10/team-10-investigates-san-diegans-describe-popular-antibiotic-causing-devastating-side-effects?fbclid=IwAR1XQQ6oPBY-4hVuFRh918enZ8FKeAjwlNxgROVV8r6YgHScn0y5QpA8dt0
On September 20, ABC News in San Diego aired this story about the debilitating and potentially deadly side effects of a popular group of antibiotics called fluoroquinolones. “We have suicides after 1 or 2 days of antibiotics”, says Dr. Charles Bennett. He’s a nationally recognized medication safety expert and says it’s a big problem. A review of the FDA’s data shows more than 20,000 reports of psychiatric side effects, like anxiety and depression and 174 suicides connected to these antibiotics since 1998.”
Know Your Drugs
Tinnitus, nerve damage and a racing pulse from just TWO antibiotic pills… Despite warnings, some doctors are still prescribing drugs that can leave patients with crippling side-effects
By JO WATERS FOR THE DAILY MAIL
PUBLISHED: 22:03, 14 September 2020 | UPDATED: 22:03, 14 September 2020
https://www.dailymail.co.uk/health/article-8732343/Some-doctors-prescribing-antibiotics-leave-patients-crippling-effects.html
‘My GP decided to prescribe stronger fluoroquinolone antibiotics [called ofloxacin] after a seven-day course of a milder antibiotic [doxycycline] hadn’t worked,’ says Adam, 32, an NHS psychologist who lives in Carlisle, Cumbria.
There were 589,116 prescriptions dispensed in 2019, according to NHS Digital, just less than 2 per cent of the 35 million antibiotics prescribed every year. And there have been more than 2,000 reports of adverse drug reactions (ADRs) for fluoroquinolones since 2014. Most ADRs are not reported.
(In his evidence to the EMA, Dr Millar argued that the complication rate was not 1 per cent, as reported, but up to 15 per cent, and so quinolones should only be prescribed for the most serious cases in hospitals, but this was rejected by the EMA and the MHRA.)
Dr Millar is working on a research project on quinolone toxicity with Professor Sir Munir Pirmohamed, NHS chair of pharmacogenetics and director of the Centre for Drug Safety Science at Liverpool University. Professor Pirmohamed says: ‘What has been discovered more recently is that patients can be affected by multi-system side-effects, including memory problems, nerve pain, lethargy and fatigue.’
I was given Vancomycin for febrile neutropenia when I was in cancer treatment. After this happened a second time, the oncologist took a new tack. I was given repeated doses of Ciprofloxacin after every chemo treatment, to prevent me from becoming febrile so that I wouldn’t wind up in the hospital again and again. (And yes, I was already taking white cell colony stimulators, but they didn’t stimulate well enough.)
I developed excruciating tooth pain at the roots of every tooth in my mouth. And I do mean excruciating. My oncologist, in his clinic notes, said I had complained of “some” pain in “one” tooth. Ha! I couldn’t have been clearer about my issues. But he chose to disbelieve/ignore me.
To this day, I continue to have off and on pain in one section of my jawline. I can only imagine that it’s due to some kind of weakening of the collagen that keeps my teeth firmly in my head. No one seems to know why this is happening, for certain, though. From the manufacturer and the FDA down to the oncologist and my dentist. They deny all knowledge!
I recently filled out a survey about fluoroquinolone use and side effects for a study being conducted at the University of California at San Diego. A VERY long survey. They wanted a lot of detail. Their goal is to get respondents in the thousands–both of people who have and who have not had negative LTEs. I can’t help but wonder who is funding that research. If it’s the industry, then I have real reservations about what will become of the findings. Anyone know anything about this?