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Baycol and Muscle Damage
Baycol:
Baycol and Muscle Damage
The FDA announced
on August 8, 2001 that Bayer Pharmaceutical Division was voluntarily
withdrawing Baycol (cerivastatin) from the U.S. market because of
reports of sometimes fatal rhabdomyolysis, a severe muscle adverse
reaction from this cholesterol-lowering (lipid-lowering) product.
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 condition that results in muscle cell breakdown and release of
the contents of muscle cells, specifically, a pigment called myoglobin,
into the bloodstream. The kidneys, being a filtering mechanism, suffer
excessive stress in attempting to filter the myoglobin out of the
blood. This can possibly lead to kidney failure.
Symptoms of rhabdomyolysis
include muscle pain, weakness, tenderness, malaise, fever, dark urine,
nausea, and vomiting. The pain may involve specific groups of muscles
or may be generalized throughout the body.
Most frequently
the involved muscle groups are the calves and lower back; however,
some patients report no symptoms of muscle injury. In rare cases the
muscle injury is so severe that patients develop renal failure and
other organ failure, which can be fatal.
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a Baycol side effects lawyer who advertises having experience and
knowledge in current Baycol suits.
ref:
U.S. Food and Drug Administration Website
