August 15, 2001


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Cholesterol Medication Kills 52

Bayer Pharmaceutical's cholesterol-lowering drug Baycol has been pulled off the market after being linked to 52 deaths in the U.S. and abroad. Baycol is one of a family of drugs called statins, which are prescribed by doctors to reduce cholesterol. All statins have been linked to muscle deterioration and a fatal muscular disease called rhabdomyolysis. Baycol, however, has been linked to the most fatalities. There will be no action taken against the other statins on the market sold in the U.S., Mevacor, Pravachol, Zocor, Lescol or Lipitor.

This news comes on the heels of an announcement by the US National Institutes of Health (NIH), warning than more than 100 million Americans were at high risk of diseases related to high levels of cholesterol. The NIH study recommended putting tens of millions of Americans on expensive lifelong medications like Baycol, while making virtually no reference to the adoption of positive lifestyle changes. Missing completely from the report was any recommendation of eliminating animal products, which are the source of all external cholesterol, from one's diet. See previous Vegan News story

Rhabdomyolysis is a potentially fatal condition in which muscle cells are killed and released into the bloodstream. Rhabdomyolysis can cause severe muscle pain, is is occasionally so severe that patients develop total kidney failure.

"If the use of this medicine has resulted in damage to health, that is something we deeply regret," chief executive Manfred Schneider said at a news conference. "We do everything we can to eliminate such risks."

Baycol, also called cerivastatin, is the twelfth prescription drug to have been withdrawn from the U.S. market because of dangerous side effects in four years. Critics contend that this is due to the FDA being under political pressure to speed up pharmaceutical approvals.

Bayer executives refused to say how many rhabdomyolysis sufferers they counted worldwide, but Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said that there have been hundreds of cases.

Wolfe is preparing to petition the FDA to strengthen warnings on other statins.

"If people become aware early that they are developing this muscle disease, they can stop the drug and recover", he said.

Bayer's stock fell 20 percent in the three days after it announced the recall.

Meanwhile, Bristol-Myers Squibb Co. announced Monday that it is offering a free, one month supply of their cholesterol-lowering drug Pravachol in a bid to capture Baycol's market. Full-page ads ran in at least three major U.S. newspapers.

"We just want to make sure that Baycol users continue getting treatment," according to Bristol spokeswoman Bonnie Jacob's.

Pravachol's share of total prescriptions written for cholesterol drugs dropped to 14 percent from 21.8 percent in 1997. During that time, the number of prescriptions written for statins rose 86 percent to 96.9 million Americans, according to IMS Health, a market research firm.