A safety review of products used to treat high cholesterol is under way following pharmaceutical firm Bayer's withdrawal of the drug Lipobay, also known as Baycol.
The European Medicines Evaluation Agency said it will investigate drugs in the so-called "statin" category, used to reduce bad cholesterol, after reports that 480 people had suffered a serious muscle reaction to the drug and that more than 30 had died in the United States.
Last night neither Bayer nor the Irish Medicines Board could provide accurate figures for the numbers of Irish people taking Lipobay.
Yesterday's withdrawal followed concerns about a "rare but serious" reaction when Lipobay (cerivastatin) is used together with another lipid (fat) lowering medicine, Lopid (gem fibrozil), the IMB said. The combination of the two products can lead to rhabdomyolysis (muscle breakdown) and possible kidney damage. There have been no reports of this occurring in Ireland, however, the IMB said.
Lipobay is one of a number of so-called "statin" products used to prevent primary and secondary heart disease. Statins, the generic term for such products, act on fats in the blood, effectively reducing "bad" cholesterol while promoting "good" cholesterol.
Bayer is writing to all Irish GPs to inform them of the product's withdrawal and requesting that they return any Lipobay stock.
The company says in the letter it will continue to conduct further assessments to evaluate the risk/benefit ratio of Lipobay.
Since 1997, some six million people have been treated with cerivastatin worldwide in more than 80 countries, Bayer says.
The company advised patients taking Lipobay to contact their doctor to review the therapy.
A spokeswoman for Bayer confirmed yesterday that it had been found those taking Lipobay, as opposed to other statin drugs, in combination with gemfibrozil were more likely to suffer the condition than those taking other statins. Warnings about combining statin drugs with gemfibrozil are carried on all packs.
Simultaneous use of gemfibrozil and cerivastatin is low, but Bayer had continued to receive reports of myopathy/ rhabdomyolysis from the concomitant use of the two drugs despite its "diligent attempts" to avoid co-prescription.
Bayer said reports of serious adverse effects related to the concomitant use of gemfibrozil and cerivastatin were substantially lower in Europe, Asia and Latin America than in the United States.
Sales of the drug this year were valued at #636 million, the company said.
Mr David Ebsworth, head of the pharmaceutical business group of Bayer, said the company was taking the action because it had a long-standing commitment to protect the health and safety of everyone treated with its products.
Lipobay was authorised in Ireland and the rest of Europe in 1997 and is used to treat patients with high cholesterol who have not responded adequately to an appropriate diet.