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drug_recall baycolOn August 8, 2001, the FDA announced that Baycol cholesterol-lowering drug was being recalled. The decision was based on the significantly higher number of deadly side effects associated to the use of statin drug Baycol.
Baycol Recall FDA Announcement
-From the FDA Talk Paper
August 8, 2001
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:
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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