Bayer today suspended the marketing and distribution of its cholesterol-lowering drug Lipobay in Ireland.
Bayer said it was pulling Baycol/Lipobay (also known as cerivastatin) because of fears of what it called "a life-threatening side-effect".
The US Food and Drug Administration said Baycol may be linked to 31 deaths from severe rhabdomyolysis - a condition that can result in kidney and other organ failure.
The Irish Medicines Board (IMB) urged patients taking Lipobay to contact their doctor to consider alternatives.
According to an IMB statement, concerns arose about the use of the drug in conjunction with another drug called Lopid (gemfibrozil). "The combination of the two medicinal products can lead to muscle breakdown and possible kidney damage," the IMB warned.
The IMB said no reports of illnesses or reactions have been reported in Ireland to date and added the suspension was a precaution.
Bayer sent a letter to all healthcare professionals warning against the co-prescription of the two drugs at the end of June 2001.
A Bayer spokeswoman told ireland.comno complaints concerning Lipobay, which was authorised in Ireland in 1997, have been received from Ireland. She said the product was being reassessed and a decision on whether to reconfigure the drug would be made soon.