Baycol (cerivastatin) is a cholesterol lowering drug produced by Bayer Corporation. The drug was initially approved for the US market in 1997. Baycol is one of class of drugs know as "statins", which lower cholesterol levels by blocking specific enzymes in the body involved in the synthesis of cholesterol. Some statins have been associated with rhabdomyolysis, a condition that results in muscle cell degeneration and which can lead to potentially fatal kidney and other organ damage. While all statins present risk of rhabdomyolysis, there have been significantly more cases associated with Baycol than other approved statins such as Mevacor, Pravacor, Zocor, Lescol or Lipitor. Bayer withdrew the drug from the market in August 2001 after reports of 32 deaths due to fatal rhabdomyolsis.

Fatal rhabdomyolysis reports associated with Baycol have been reported when used in higher doses, when used in elderly patients, and particularly when used in combination with gemfibrozil (lopid and generics), which was often prescribed with Baycol. Bayer annouced in January 2002 that the esimated number of deaths linked to Baycol had increased to 100.

The FDA reports that the most frequent symptoms are muscle pain, weakness, nausea, tenderness, malaise, dark urine, and vomiting. The most frequently impacted muscle groups are the calves and lower back area. The FDA cautions, however, that some patients report no symptoms of muscle injury. The FDA is urging Baycol users to immediately consult their doctor.

Since its withdrawal form the market, numerous lawsuits have been filed against the manufacturer. Some plaintiffs allege that Bayer had continued to aggressively market Baycol as a safe and effective drug after it had received reports and evidence of serious side effects.

In May 2003, Bayer announced that it had spent $240 million on settling 785 Baycol cases. On June 2003, Bayer announced that the number of out of court Baycol settlements had risen to 1,042, and that it currently had 9,400 cases pending against it.

December 2004 Baycol News Update:  In November 2004, the FDA launched a review of its records of the August 2001 recall of Baycol in light of recent allegations that the pharmaceutical company was aware of the risks associated with the drug but failed to inform the FDA of its findings in a timely manner. Five articles recently published in the Journal of the American Medical Association examined the Baycol recall, which occurred after reports had linked the drug to at least 31 deaths related to rhabdomyolysis. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington, and colleagues said in one JAMA article that Bayer was aware of the risks of Baycol long before it withdrew the drug from the market. Citing internal Bayer documents that have became public, the professor and colleagues said that Bayer became aware of the possibility of a link between Baycol and rhabdomyolysis within months of the drug's launch in February 1998. The professor concluded that under the current system, a pharmaceutical company's "appraisal of (suspected adverse drug reactions) may be influenced by economic considerations." By the time Bayer removed Baycol from the market in 2001, the estimated number of cases of rhabdomyolysis had reached into the thousands. According to the Kaiser Daily Health Policy Report of November 23, 2004, Bayer has settled 2,861 injury lawsuits about Baycol.

2005 Update: In the coordination multidistrict lawsuit concerning nationwide Baycol litigation, the Plaintiffs' Steering Committee (PSC) for the coordinated Baycol litigation recently filed a proposal with the Baycol court, directing the nationwide Baycol case known as the MDL proceedings toward desired resolution of all Baycol lawsuits subject to the multidistrict litigation proceeding by the end of 2005.