Why ARE doctors still doling out antibiotics that have left thousands in crippling pain?
MOST of us take antibiotics, grateful for a reliable cure, with little thought for the potential side-effects.
But concerns are mounting about adverse reactions caused by a group of widely-prescribed antibiotics called quinolones and fluoroquinolones. In some people, even a short course of the pills can cause long-term, even permanent damage including tendon rupture, joint problems and nerve pain.
Last month, patients affected testified to the regulator, the European Medicines Agency (EMA), in a public hearing as part of a review by the safety committee.
This was only the second-ever public hearing held by the EMA (the first was into the epilepsy drug valproate, which can cause birth defects in pregnant women). It is being viewed as a sign that long-standing concerns about these antibiotics are finally being taken seriously.
Quinolones and fluoroquinolones are broadspectrum antibiotics: fluoroquinolones are the newer drugs and more frequently prescribed.
They work against a number of bacteria including salmonella and E.coli, and are commonly used to treat recurrent urinary tract infections (UTIs), prostatitis — inflammation of the prostate — and serious lung infections.
Ciprofloxacin, a fluoroquinolone, is the most prescribed of the group; others include levofloxacin, moxifloxacin, and norfloxacin.
In the US, the drugs carry prominent health warnings on the labels highlighting the risks of tendonitis (inflamed tendons), tendon rupture and irreversible nerve damage.
The latest alert issued two weeks ago by the US drugs regulator, the Food and Drug Administration (FDA), highlighted a risk of brain-related side-effects such as memory impairment, delirium, agitation and disorientation. It warned healthcare professionals: There is a potential risk of hypoglycemia associated with use that sometimes may result in coma; elderly patients and those taking oral hypoglycemic agents or insulin may be at increased risk;
Psychiatric adverse reactions may occur after just one dose;
Treatment should be discontinued if patients report any CNS side-effects, including psychiatric adverse events, or blood glucose disturbances; switching to a nonfluoroquinolone antibiotic should be considered if possible;
If serious side-effects involving the tendons, muscles, joints, or nerves occur, treatment should be stopped and patients should be switched to a non-fluoroquinolone antibiotic, and
Fluoroquinolones should not be prescribed for acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, and uncomplicated urinary tract infections if patients have other treatment options because the risks outweigh the benefits.
IT’S thought that because fluoroquinolones act on mitochondria — powerhouses in cells responsible for energy — the effects can be felt all over the body.
Laboratory research also suggests the drugs can provoke a reaction specifically in tendon cells, leading to the production of enzymes that ‘degrade’ the tendon, causing it to break down prematurely.
Campaigners are frustrated — and claim patients are being prescribed fluoroquinolones for minor infections when other antibiotics are available, and that patients aren’t warned about side-effects.
Sufferers of side effects complain of ongoing, painful and disabling problems with tendons, muscles and nerve pain.
‘Side-effects are grossly underreported,’ says Neal Millar, who gave evidence at last month’s hearing.
‘The complication rate — including tendon rupture, tendonitis, nerve pain and joint problems — is reported as between 1% and 3%, based on official reports. But, in my experience, it’s closer to 10% to 15%.
‘Hundreds of thousands could be affected and the majority will not have connected their symptoms with taking a fluoroquinolone, and of those who have realised, the majority struggle to make doctors believe them.
‘It shocks me how medical professionals dismiss these patients,’ he told Good Health.
‘The FDA has issued five warnings in ten years — why are we only just having this hearing in Europe?’
Mr Millar says one of the problems is that the side-effects can take weeks to appear, so most people don’t make the link.
Lyn How, 68, one of the patients who gave testimonies to the EMA, was prescribed ciprofloxacin by her GP before travelling on holiday to India.
She developed a painful urinary tract infection (UTI) and took the tablets, which ‘worked brilliantly’. The next day though, Lyn developed intense pain in her feet.
‘I felt as though I’d been shot in my right foot — it was excruciating,’ says Lyn, who lives with husband Nick, 68
‘We were flying home the next day and I had to get a wheelchair to take me through the airport.’
Back home, Lyn read the information leaflet and noted tendon problems were a known sideeffect, especially if you already had a tendon issue.
‘I’d previously complained of tendon pain in my feet and my GP admitted he should have listened to me,’ she says.
He referred Lyn for scans that confirmed one of the tendons on her right foot had ruptured and another was in danger.
‘The orthopaedic surgeon said it might have been caused by ciprofloxacin,’ she says. ‘He suggested I try physiotherapy, but it was extremely painful.’
Lyn’s symptoms intensified and, barely able to walk, she eventually had an operation on her tendon in November 2012, eight months after her trip to India.
But a year later she was still using crutches and in constant pain. Lyn sued her GP on the grounds that guidelines advise ciprofloxacin should be used with caution in people over 60 or with tendon problems. She won an outof-court settlement in 2015.
‘It wasn’t until 2016 that a rheumatologist diagnosed me with quinolone-associated musculoskeletal systemic toxicity,’ she says.
‘I’m much better than I was, but have been left with nerve damage in my legs and can’t walk very far.’
Elizabeth Carmouche, 50, travelled from her home in Brussels, where she works as a translator, to give evidence at the EMA hearing in London.
She was prescribed ciprofloxacin before a three-week holiday ‘in case I developed UTIs or traveller’s diarrhoea’, she says.
‘I took a tablet after developing cystitis and three weeks later, back home, I developed terrible pain in my bones, tendons and joints — it gradually spread all over my body.
‘I struggled to walk up the stairs and my wrists were so painful I couldn’t even turn a door handle. ‘I researched my symptoms online and ciprofloxacin kept cropping up, so I told my GP I thought my symptoms were connected. She dismissed my concerns and said I had rheumatism.
‘Between May and September 2016, I saw three specialists — a rheumatologist, an orthopaedic consultant and a neurologist, but not one of them acknowledged ciprofloxacin may be to blame.
‘They tested me for Lyme disease and lupus [an auto-immune disorder] but all tests were negative. I tried physiotherapy, but it made it worse.’
This is a common problem, says Mr Millar — it’s important patients see a physiotherapist who specialises in tendon problems as some techniques ‘may load the tendons too much’, exacerbating the problem.
‘It was only when I found Mr Millar’s research on tendon problems and contacted him that I got some acknowledgement of what was wrong,’ says Elizabeth. ‘It was such a relief to be believed.’
Two years on, she still has painful joints and has to work from home three days a week as driving puts strain on her knees.
Campaigners are quick to highlight that this is not a historic problem and people are still being ‘floxed’ — as they call it.
Stacey Rodger, a council waste manager, who lives with her two young children, was prescribed ciprofloxacin 15 months ago for a kidney infection.
‘I’m very cautious about my health because I suffer from fibromyalgia,’ she says.
‘When I read the leaflet and noticed the warning about tendon problems I rang an out-of-hours doctor to ask for an alternative.
‘I was told not to be ridiculous and that if we all read the sideeffects, no one would take any drugs. It was a bank holiday and I was in severe pain so I reluctantly took the antibiotics.
‘After the third dose, I noticed bad pain in my legs and a sensation that felt like popcorn popping under my skin.’
STACEY is still in severe pain and has spent more than €2,500 seeing osteopaths and chiropractors. ‘I’m better than I was, but I still have a long way to go,’ she says.
Mr Millar says patients with ongoing symptoms should ask their GP for a referral to a rheumatologist, specialist tendon physiotherapist or orthopaedic surgeon.
He hopes the EMA’s review will recommend the restriction of prescriptions for fluoroquinolones.
‘These drugs should be prescribed only by specialists for patients with no alternative,’ he says.
Bayer, which makes Ciproxin (ciprofloxacin) and Avelox (moxifloxacin) said it welcomes the investigation.
A spokesman said: ‘Bayer is in continuous scientific dialogue with health authorities and medical communities to ensure safety information is up to date.’