By Alasdair Soussi

LIZZI Aitkenhead rarely ventures outside nowadays. The married 43-year-old, who lives in Bridge of Weir, once had plans, a career and a full life, but is today limited to a world of four walls – and a crushing uncertainty over her long-term future.

Aitkenhead blames her crippling agoraphobia on anxiety induced by ciprofloxacin – an antibiotic of the fluoroquinolone drug class. She was prescribed ciprofloxacin – or cipro, for short – in September 2017 for a urinary tract infection (UTI). What followed, she said, was a series of adverse reactions that saw her health decline as she battled to regain control of her body.

The native South African, who has been living in Scotland since 1999, said that after taking six tablets, of a 10-tablet course, she began to experience sensitivity to sound, burning in her hands, ringing in her ears (tinnitus), anxiety, agitation and pains in her arms and feet. Today, as she continues to struggle with everyday life, she also claims to live with “crunching” joints and “severe fatigue”.

“I hasten to add that health-wise, there was absolutely nothing wrong with me – I was fit and well and had no physical health problems [prior to taking cipro last year],” Aitkenhead told The Herald on Sunday of her experience with a drug she said she had taken before without any “apparent ill-effects”.

Aitkenhead’s story is nothing new, with Scotland just one of many countries across the world featuring stories of human suffering involving fluoroquinolones. On October 5, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended “new restrictions” on the use of quinolones and fluoroquinolones, following a June public hearing concerning the reported side-effects of these widely prescribed antibiotics. (Fluoroquinolones are today the most commonly prescribed of these antibacterial agents as compared to the first generation quinolones). The EMA, a decentralised agency of the European Union (EU), heard contributions from across Europe, with medical professionals and sufferers alike relating the existence of so-called fluoroquinolone toxicity.

Neal Millar is a senior clinical lecturer in orthopaedics at the University of Glasgow. He told The Herald on Sunday that, in the likes of the UK, there has been a tendency from the medical community to dismiss patient concerns about fluoroquinolones.

“All the basic science evidence [about fluoroquinolone toxicity] has been out since the late 1990s and early 2000s,” said Millar, who is also an honorary consultant orthopaedic surgeon, and was one of the medical professionals who gave evidence at the EMA hearing.

“And yet these people were just told, ‘oh no, you only took two tablets, that couldn’t possibly affect you.’”

Patients who have experienced side-effects after taking tablets such as cipro for health issues like a UTI or prostatitis have presented with a variety of complaints, the most common being of the musculoskeletal variety – not least tendon and joint problems. Neurological issues have also been recorded with some fluoroquinolone toxicity sufferers being confined to a wheelchair in extreme cases.

Martyn Black has no doubts that fluoroquinolone antibiotics, which have cured complex health conditions across the world, are the culprit for his current mobility issues. Black, a former company director from Aberdeen, said that four different experiences with fluoroquinolones, from the late 1990s onwards, are responsible for his stated spinal problems.

“Each time I had the drug, I’ve had a breakdown of my spine,” the 58-year-old told The Herald on Sunday.

Black attributes his crippling back ailments to “collagen-loss” – a condition that some medical studies have associated with fluoroquinolone toxicity.

In the UK, fluoroquinolones are often doled out for relatively uncomplicated conditions. In England, where Aitkenhead happened to be when she was prescribed her cipro tablets last year, 675,000 prescriptions for fluoroquinolones were handed out in primary care in 2017. Hard statistics on adverse side-effects are difficult to come by in the UK, but there have been 5,338 suspected adverse drug reaction reports, involving cipro alone between 1986 and the present day, through the Yellow Card Scheme – the British system for recording adverse events with medicines and medical devices. Campaigners contend that this is a grossly under-reported figure, however, stressing the authorities have not woken up to the threat posed by fluoroquinolones.

When The Herald on Sunday approached the Medicines and Healthcare products Regulatory Agency (MHRA) for comment about its own policy towards fluoroquinolones, an MHRA spokesperson stated: “Fluoroquinolones play an important role in the treatment of serious bacterial infections, especially hospital-acquired infections and others in which resistance to older antibacterial classes is suspected.

"MHRA has taken part in the ongoing EU review of disabling and potentially long-lasting side effects of fluoroquinolones. Once the review is finalised, the licences in the UK will be updated and we will communicate the new advice to healthcare professionals and patients.”

Millar has witnessed first-hand the “toxic” reactions of fluroquinolones on human tendon cells — via clinical trials.

“It had been done before, but we wanted to show that it was very toxic to the tendon cells and were killing them at dosages you would use in clinical practice,” explained the academic orthopaedic surgeon.

Tendon issues came fast for Sheila Lochrie after she was first prescribed cipro for diverticulitis — a gastrointestinal condition — just a few short years ago.

“In retrospect, my sore feet and the tight tendons arrived almost immediately,” said the 71-year-old from Edinburgh. She now manages a series of physical symptoms she maintains are caused by her fluoroquinolone dosages.

Stories of consulting doctors effectively dismissing complaints from patients about fluoroquinolones are a common theme for sufferers both north and south of the Border.

For many sufferers and concerned medical practitioners, the EMA’s involvement in the fluoroquinolone issue was final recognition of a longstanding concern.

The recommendations, still to be adopted in full by the EMA, were the latest instalment in a medical controversy which, as far as drug side-effects are concerned, Millar classes as “a grossly under-recognised drug reaction” that “ruins lives”.

“The recommendations don’t really amount to much more than what the warning leaflets say already,” Miriam Knight of Quinolone Toxicity Support UK told The Herald on Sunday.

“They annoyingly talk about ‘very rarely’, which is something we laboured long and hard at the review: how can people report it or know they have it if very few doctors recognise it?”

Bayer, the drug manufacturer of cipro, was approached for comment by The Herald on Sunday but was unable to provide an updated statement on the PRAC recommendations.

In an earlier statement, however, it said: “Bayer has been in continuous scientific dialogue with health authorities and medical communities to ensure that safety information is up to date to help guide the assessment of the benefit and risk of treatment for the individual patient.”

As for Aitkenhead – who also took issue with the PRAC reference to the rarity of the side-effects, but expressed hope that the recommendations would lead to “a better understanding” of her condition – she sits at home dreaming of a time that she can one day return to her job as a data analyst.

She is, by her own admission, “a shadow” of the woman she once knew.

“I do try to stay positive and sincerely have to hope and believe that I will continue to feel better and be back at work at some point,” said Aitkenhead with her soft South African lilt.

“But I do worry that that won’t happen.”