On August 8,
2001, Bayer Pharmaceutical removed the cholesterol drug Baycol from
the market after reports of at least 40 deaths linked to use of
the drug. According
to the Food and Drug Administration (FDA), Baycol has been linked
to numerous fatal cases involving an adverse muscle reaction known
as rhabdomyolysis.
Baycol (cerivastatin),
which was initially approved in the U.S. in 1997, is a member of
a class of cholesterol lowering drugs that are commonly referred
to as "statins." Statins lower cholesterol levels by blocking
a specific enzyme in the body that is involved in the synthesis
of cholesterol. 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.
Fatal rhabdomyolysis
reports with Baycol have been reported most frequently when used
at higher doses, when used in elderly patients, and particularly,
when used in combination with gemfibrozil (LOPID and generics),
another lipid lowering drug. FDA has received reports of 31 U.S.
deaths due to severe rhabdomyolysis associated with use of Baycol,
12 of which involved concomitant gemfibrozil use.
Rhabdomyolysis
is a life threatening condition in which muscle cells breakdown
and release the contents of the muscle into the blood stream. According
to the FDA, symptoms of rhabdomyolysis include muscle pain, weakness,
tenderness, fever, dark urine, nausea and vomiting. The lower back
and calve areas are the most frequently impacted areas of the body.
The FDA advises that in certain cases, the muscle injury is so severe
that patients develop renal failure or other organ failure, which
may be fatal.
700,000 Americans
have taken Baycol. The FDA advises persons using Baycol to promptly
consult their doctor.
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