Irish Daily Mail

Why ARE doctors still doling out antibiotic­s that have left thousands in crippling pain?

- By JO WATERS

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.’

 ??  ??

Newspapers in English

Newspapers from Ireland