Bayer: FDA reports link to deaths

August 8, 2001 Posted: 1550 GMT

WASHINGTON, (Reuters) - Bayer AG's cholesterol- fighting drug Baycol, which the German drug giant pulled from the market Wednesday, was linked to 31 U.S. deaths from a muscle-related side effect, health officials said.

The Food and Drug Administration said it agreed with Bayer's decision to withdraw voluntarily the drug from the market. Baycol, part of class of cholesterol drugs called statins, was approved in the United States in 1997.

The agency said it received reports of Baycol patients experiencing severe rhabdomyolysis, a condition that results in muscle-cell breakdown and causes muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting.

In some cases, rhabdomyolysis is so severe that patients develop failure of the kidney or other organs, which can be fatal, the FDA said.

“FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol,” the agency said in a written statement.

Twelve of the 31 deaths involved patients taking another drug, gemfibrozil, the FDA said.

“While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins,” the FDA said.

Baycol patients who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician, the FDA said. Others taking Baycol should talk to their doctors about switching to alternative medications, the agency advised.

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