The Baycol / Lipobay - Scandal

Baycol News Prompts EU Review of Cholesterol Drugs

LONDON (Reuters / August 9, 2001) - The European Medicines Evaluation Agency announced on Thursday a safety review of other drugs in the same class as Bayer AG's cholesterol-lowering agent Baycol, which was withdrawn after being linked to 31 deaths in the United States.

Noel Wathion, head of the London-based agency's drug evaluation unit, told Reuters: ``There is a need to look at the whole class of these products to see if there is a need for further action.''

He said 480 reports of a sometimes fatal muscle reaction called rhabdomyolysis had been received globally from patients taking Baycol.

He did not know how many patients had died in addition to the 31 U.S. deaths already reported by the U.S. Food and Drug Administration (FDA).

Wathion said the review -- by the agency's pharmacovigilance working party -- would focus on the class of drugs known as statins, with a similar chemical make-up to Baycol.

The statins were introduced in 1987 and have quickly become blockbuster drugs with total annual sales now worth over $14 billion. Leading products include Pfizer Inc's Lipitor, Merck and Co Inc's Zocor and Bristol-Myer Squibb Co's Pravachol.

The FDA said fatal reports with Baycol had been reported most frequently when the drug was used at higher doses, in elderly patients, and especially when taken in combination with another cholesterol-lowering drug called gemfibrozil.

It said patients taking Baycol should consult their physicians about switching to another medication to control their cholesterol agents.

It pointed out that there were five other statins available in the United States -- Mevacor, Pravachol, Zocor, Lescol and Lipitor -- ``that may be considered as alternatives to Baycol.''

Rhabdomyolysis results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms include muscle pain, fever, weakness and vomiting.

Germany's Bayer shocked investors and sent its share price into a tailspin on Wednesday when it announced the withdrawal of top-selling Baycol.