| U.S. Food and Drug Administration |
FDA Talk Paper, August 8, 2001
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.
The FDA posts press releases and other notices of recalls from the firms involved as a service to consumers, the media, and other interested parties. The FDA does not endorse either the product or the company.
The text in this article was prepared by the FDA Office of Public Affairs.