Researchers revisit Baycol withdrawal

Researchers published in the Journal of the American Medical Association that there was an "asymmetry between the information available to the company and the information available to patients and physicians" related to Bayer's Baycol cerivastatin. Bayer (FSE:BAYG; BAY) pulled the cholesterol drug from the market in 2001 because of side effects related to rhabdomyolysis (muscular weakness), especially in patients simultaneously receiving gemfibrozil, a fibric acid derivative.

In the JAMA article, the researchers said internal BAYG documents suggested an interaction between Baycol and gemfibrozil "within approximately 100 days of the launch in 1998; however, the company did not add a contraindication about the concomitant use of cerivastatin and gemfibrozil to the package insert for more than 18 months." Also, they said BAYG had post-marketing data on Baycol from 1999 and 2000 showing a higher rate of rhabdomyolysis than in patients receiving Lipitor atorvastatin from Pfizer (PFE). "To our knowledge, these findings were not disseminated or published," the researchers said. The researchers concluded that Congress should mandate and support independent reviews of post-marketing data. ...