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class as Bayer AG's cholesterol-lowering agent Baycol, which was withdrawn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. |
