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Bayer AG Pulls Cholesterol Drug Baycol

Reuters news service reports on August 8, 2001 that German drug company Bayer AG has taken its controversial cholesterol drug Baycol off the market after 31 people taking the drug died from a rare muscle-cell disorder.

The FDA reports that it agreed with the decision. Baycol (chemical name cerivastatin), is in a class of cholesterol drugs called statins, and was approved for use by the FDA in the United States in 1997.

The muscle-cell disorder is called rhabdomyolysis and causes muscle-cell breakdown, muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea and vomiting. In extreme cases rhabdomyolysis is so severe that patients can develop kidney and other organ failure leading to death.

In a related story on August 20, 2001, Reuters Health news service reported that the Washington DC-based consumer advocacy group Public Citizen has filed a petition with the FDA urging them to require a 'black box warning' on all statin drugs. 'Black box warnings' are the strongest labeling caution the FDA can require.

The statin drugs that Public Citizen wants labeled are Pravachol (pravastatin), Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin) and Zocor (simvastatin).

Oddly after Bayer pulled Baycol, the FDA suggested that doctors switch their patients to these other statin drugs, but they have also been associated with hundreds of recent reports of rhabdomyolysis as well. 772 cases of rhabdomyolysis associated with all of the statins were reported between October 1997 and December 2000, accounting for a total of 81 deaths.

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