Baycol

German drug manufacturer Bayer AG pulled their popular cholesterol lowering drug, Baycol from the market. Baycol was withdrawn from the market because it has been linked to 31 US deaths from a muscle-related side effect, according to the US Food and Drug Administration. Baycol is one of an extraordinarily popular family of cholesterol-lowering drugs called "statins." Baycol was approved in the United States by the FDA in 1997.

The FDA had received reports of Baycol patients experiencing severe rhabdomyolysis. Rhabdomyolysis is a condition that causes muscle-cell breakdown (atrophy) and causes muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting.

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

In a written statement the said, "the FDA has received reports of 31 US deaths due to severe rhabdomyolysis associated with use of Baycol.'' 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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