Baycol Recall Information

Bayer Recall of Cholesterol Drug Baycol

Baycol is Bayer's trade name for the drug cerivastatin, which is a member of the popular class of cholesterol drugs commonly called "statins."

According to a United States Food and Drug Administration statement released on August 8, 2002, reports of 31 U.S. deaths linked to the cholesterol-lowering drug Baycol led to Bayer pulling Baycol off the market.

Although other drugs of the statin class have been linked to a life-threatening condition called rhabdomyolysis, the condition was seen most frequently in patients taking Baycol.

Rhabdomyolysis is a rare disorder involving injury to the kidney caused by toxic effects of the contents of muscle cells.

In more detail, when the skeletal muscle is damaged, an iron-containing pigment found in the skeletal muscle called myoglobin, is released into the blood stream. Myoglobin is filtered out of the blood stream by the kidneys, but the process may occlude the structures of the kidney and cause acute renal failure secondary to myoglobinuria.

Most of the injuries and deaths reported to the FDA occurred in elderly patients, people who used higher doses of Baycol, and anyone who used Baycol and Lopid (gemfibrozil) together.

On May 21, 2001, Bayer issued a letter to health care professionals warning of high dosage risks and adverse drug interaction with Lopid.

On August 8, 2001, Bayer issued another letter to health care professionals announcing its withdrawal of Baycol from the market.

A spokesman for GlaxoSmithKline, another drug company, said there was an agreement between Bayer and GlaxoSmithKline which involved the marketing and sale of Baycol in the U.S. The agreement agreement did not involve sales outside the U.S.

The FDA has advised patients on Baycol to consult with their physicians about switching to alternative medications.

Further, the FDA cautions that if a patient is experiencing muscle pain or also taking Lopid (gemfibrozil), they should stop taking Baycol immediately.

The FDA said the five other statins can be considered alternatives to Baycol - they are Mevacor and Zocor by Merck & Co., Lipitor by Pfizer Inc., Pravachol by Bristol-Myers Squibb Co., and Lescol by Novartis AG.

Baycol is also known as Lipobay in some countries outside of the U.S.

We encourage you to find out more about your particular legal situation by taking advantage of the Free Baycol Case Evaluation service we offer on this site.