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drug to have been withdrawn from the U.S. market because of dangerous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.
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August 15, 2001
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Cholesterol Medication Kills 52