I n a phone call to the medicines control agency on the evening of August 7, the German drugs firm Bayer dropped a bombshell that stunned the medical community across Europe. The company told the agency's duty officer that it wanted to withdraw Lipobay, a cholesterol-lowering drug that was part of a cutting-edge group of medicines known as statins. Bayer said the request was urgent. It wanted Lipobay, also known as Baycol, cleared from pharmacists' shelves the next morning. It had been "linked", the firm said coyly, to cases of "muscle weakness".

The following day, doctors clamoured for more information. The withdrawal of such a popular drug was unusual. Lipobay had been prescribed more than 1.5m times since its launch in 1997. Along with other statins, Lipobay was viewed as a long-awaited breakthrough in controlling cholesterol, the waxy, fat-like substance that clogs up the bloodstream.

Graham Jackson, a consultant cardiologist at Guy's and St Thomas's hospitals, in London, was astonished by the news. "These statins are the first things we've had for cholesterol that actually work properly," he says.

Bayer's response was reassuring. It said Lipobay's withdrawal was purely precautionary. According to the company, the drug caused problems only on the highest daily dose of 0.8mg, or when it was used with another circulatory drug, gemfibrozil.

Those soothing words disguise devastating side-effects, details of which are only now coming to light. Discussing the drug brings tears to the eyes of Alice Holloway, a 76-year-old from Eltham in south London.

Her husband Ron, 77, was prescribed Lipobay in August last year after complaining to his GP that he felt under the weather. "I was just feeling off-peak," he says. "Tired, and a little bit down." He was told to take one 0.4mg tablet of Lipobay a day - below the "danger limit" later conceded by Bayer. Within two weeks, he was feeling worse. "He was coming down in the morning, holding his hips," says Mrs Holloway. "He said his legs and his hips were feeling weaker and weaker."

Puzzled by his symptoms, the Holloways' GP called in a specialist from Greenwich district hospital. By this time, even slight pressure on his arm left Mr Holloway "in agony", while his urine was the colour of black coffee.

In December, Mr Holloway's condition deteriorated dramatically. Lapsing into semi-consciousness, he was taken to Guy's by ambulance. "By the time I got there, I was almost out," he says. "I was very, very ill."

The doctor at Guy's was so concerned that, refusing to wait for a porter, he pushed Mr Holloway's trolley to a different department to take him for a scan.

"It was all hell's bells: blood out of this arm; blood out of that arm; urine tests; questions about kidneys," says Mrs Holloway.

She stayed at her husband's bedside all day, helping him to drink cups of water. She returned home exhausted, to be woken by a late-night phone call informing her that her husband had been put on a kidney dialysis machine. In the days that followed, the muscles on his legs and thighs became "like flab; like water", his ankles grew to the size of grapefruits and his testicles became inflamed and vastly swollen.

During a six-week stay in hospital, Mr Holloway had to be lifted in a harness from his bed onto a trolley, because his legs were too weak to support him. The couple were later told be a specialist that admission "two days later would have been too late".

Initially, the couple believed that Mr Holloway's illness was connected to prostate cancer. He had been diagnosed with a small tumour months earlier. Their first indication that Lipobay was the culprit was shortly after he was admitted to hospital, when a specialist asked him to hand over his remaining tablets.

A glance at Mr Holloway's hospital records gives the true picture. It diagnoses his condition as rhabdomyolysis - the most extreme side-effect associated with Lipobay, which has afflicted five people in Britain and caused 52 deaths worldwide.

Dr David Goldsmith, a renal physician at Guy's, later confirmed to the couple that he believed that Lipobay was to blame. According to Bayer's original position, this could not be the case as Mr Holloway was taking the drug on a moderate dosage, without combining it with other anti-cholesterol therapies.

Now back at home, Mr Holloway is convalescing. He is able to walk, but becomes tired very easily. His weight, which had dropped by more than a stone, is edging back up.

The couple are both angry that a prescription drug could misfire so badly. "This musn't happen to anyone else, what's happened to Ron," says Mrs Holloway.

Initially, their GP suggested they could press for compensation from Bayer. Hundreds of patients in America are suing the drug firm, claiming more than £3bn in aggregate damages. The Holloways, however, are considering action against their doctor, who they believe should have spotted the side-effects earlier.

The Lipobay calamity has raised further questions about the workings of the National Health Service. Some doctors say health authorities put pressure on them to prescribe Lipobay ahead of other statins because of its lower cost - despite its shorter track record on safety. More than 453 "adverse reactions" to the drug have been reported to the medicines control agency, although many amount to little more than headaches, dizziness and insomnia.

For Bayer, the fallout has been disastrous. The company, which is best known for inventing aspirin, but also produces the anti-anthrax drug Cipro, considered pulling out of pharmaceuticals following a plunge in its shares price on news of Lipobay's side-effects. Prosecutors launched an investigation to see whether the firm had been negligent in failing to alert doctors of side- effects earlier. Bayer defends its conduct, insisting that it withdrew Lipobay as soon as it had evidence that the drug was causing problems.

The tragic saga has once more highlighted the delicate balance for the drugs industry, which often complains about the difficulty in getting new products past medical regulators. The average medicine takes 10 years and £350m to develop. But after the most rigorous clinical trials, a handful of dangerous products still slip through the net each year.

"I was so angry when I found out," says Mrs Holloway. "If I'd known, I would never have kept giving him those tablets when he was ill."