The withdrawal of the cholesterol-lowering drug cerivastatin (Lipobay) by the pharmaceutical company Bayer will affect patients in the Republic.
Lipobay, also known as Baycol, is one of the statin group of drugs. Figures from the General Medical Services Board (GMS) show that over 175,000 prescriptions for statin medication were issued to medical card patients in 1998. Statins accounted for 96 per cent of all lipid-lowering agents prescribed in the State.
Statins are now routinely prescribed for patients with a history of coronary heart disease. If you have had a heart attack in the past or suffer from angina you are likely to be taking one of these drugs in an effort to prevent further cardiac problems. This so-called "secondary prevention" of heart attacks and strokes has been well proven in a number of large, multi-country clinical trials.
Lipobay was withdrawn after patient deaths were linked to the use of the drug. Thirty-one patients suffered fatal episodes of rhabdomyolysis, a severe muscle disorder in which the muscle fibres begin to self-destruct. A dozen of the 31 patients who died were also taking a lipid-lowering drug called gemfibrozil (Lopid).
The kidneys are overwhelmed by waste products from the muscle breakdown and acute renal failure occurs. This appears to have been the process which led to the 31 fatalities.
Prescribing information supplied to doctors advises against the concurrent use of statins and gemfibrozil. High doses of statins alone can also cause rhabdomyolysis.
Lipobay became available in a high-dose 800 microgram tablet in August 2000 and it has been suggested that in most of the 19 cases of rhabdomyolysis in which Lipobay alone was implicated, patients had been started directly on the highest dose.
It is important to emphasise that patients taking all other types of statin medication should have no immediate concerns following the withdrawal of Lipobay. The European Medicines Evaluation Agency, Europe's drug evaluation body, has announced it will be reviewing the other statins on the market "as a precautionary measure".
The other statins on the Irish market include:
Lipostat/pravastatin
Lipitor/atorvastatin
Lescol/fluvastatin
Zocor/simvastatin
Pharmaceutical companies were yesterday advising doctors of the importance of at-risk patients not stopping medication, the withdrawal of which could increase the risk of a life-threatening cardiovascular occurrence.
Patients who are taking Lipobay in conjunction with Lopid should stop taking both drugs and seek immediate medical advice. Patients taking Lipobay alone in low dosage and who are not experiencing muscle pains should contact their doctor during this week.
The majority of patients - those taking Lipostat, Lipitor, Lescol and Zocor - should continue taking their medication as before.
The German pharmaceutical giant Bayer acknowledged yesterday that its anti-cholesterol drug may be linked to 52 deaths. Bayer said the deaths occurred following treatment with Baycol's active ingredient, cerivastatin. It said the chances of the drug returning to the market were "slim".
"If the use of this medicine has resulted in damage to health, that is something we deeply regret," said Bayer's chief executive, Mr Manfred Schneider. He stressed there was no proof that the drug caused the deaths.
The German Health Ministry said it ordered a report from regulators into whether the drug should have been recalled earlier.
Bayer's stock dropped by 20 per cent in three days after it announced it was withdrawing Baycol last Wednesday because of possible links with patient deaths. --(AP)