BAYER
VOLUNTARILY WITHDRAWS
BAYCOL
FDA
today announced that Bayer Pharmaceutical Division is
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. The FDA agrees with and supports
this decision.
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 into the
bloodstream. 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.
Bayer
Pharmaceutical Division has announced plans to withdraw
Baycol to the pharmacy level. Pharmacies will be instructed
to return the product to the manufacturer for a refund.
Patients
who are taking Baycol should consult with their physicians
about switching to alternate medications to control
their cholesterol levels. Patients taking Baycol who
are experiencing muscle pain or are also taking gemfibrozil
should discontinue Baycol immediately and consult their
physician.
There
are five other statins available in the U.S. that may
be considered as alternatives to Baycol. They are: lovastatin
(Mevacor), pravastatin (Pravachol), simvastatin (Zocor),
fluvastatin (Lescol), and atorvastatin (Lipitor).
For
further information regarding the withdrawal of Baycol,
patients and physicians can contact Bayer Customer Service
1-800-758-9794 or the FDA's Drug Information Office
at 301-827-4573 or 1-888-INFO-FDA, or go to "Baycol
Information" on FDA's Website.
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