Bayer Voluntarily Pulls Baycol (Cerivastatin)
From Markets Worldwide

　　 August 9, 2001 -- Bayer has voluntarily withdrawn its cholesterol-lowering drug Baycol (cerivastatin) from the markets in every country worldwide, with the exception of Japan, citing a rash of deaths and severe drug reactions.

　　The company announced the withdrawal in a telephone conference call with journalists Wednesday (August 8). The drug was not taken off the market in Japan because gemfibrozil is not available there.

　　According to the US Food and Drug Administration, there have been 31 deaths among American patients taking the drug since January 2000. Nineteen of the deaths are believed to have occurred among patients who took more than Bayer's recommended starting dose of 0.4 mg/day.

　　However, 12 deaths occurred while the patients were taking concomitant gemfibrozil (Lopid, Parke Davis), a combination therapy.

　　According to Bayer, 1.5 percent of the Baycol prescriptions in the US and 0.3 of prescriptions in Europe are written in conjunction with a prescription for gemfibrozil.

　　Adverse reactions between cerivastatin and gemfibrozil were first reported in 1996.

　　Baycol was approved for sale in the US in 1997, and Bayer asked the FDA in December 1999 for a labelling change to contraindicate taking Baycol with gemfibrozil. The company then upgraded its promotional wording in April 2001 to advise doctors to start patients off at the lower 0.4 mg dose, and followed that up with a "Dear Healthcare Provider" letter in June 2001 alerting physicians to the gemfibrozil contraindication.

　　"The reason for the voluntary action -- and I stress that it is a voluntary action -- is that we have been seeing an increasing number of reports of side effects involving muscular weakness -- rhabdomyolysis," Philip Blake, executive vice-president and general manager Bayer's healthcare division in Canada, told Doctor's Guide. Rhabdomyolysis is a potentially fatal disease which causes destruction or degeneration of skeletal muscle and often associated with myoglobinuria.

　　"We continued to see this increase, despite having instituted a contraindication, and subsequent to the contraindication, we disseminated a 'dear doctor' letter and an advisory," he added.

　　According to the FDA, other statins can be considered alternatives to Baycol: Mevacor (lovastatin, Merck) and Zocor (simvastatin, Merck), Lipitor (atorvastatin, Pfizer), Pravachol (pravastatin, Bristol-Myers Squibb), and Lescol (fluvastatin, Novartis AG).

　　However, the risk of adverse drug interactions is not unique to Baycol. According to Neil Maresky, MD, Bayer's vice-president of medical and scientific affairs in Canada, "it is my understanding that all statins have a warning" against using them in combination with gemfibrozil. This warning is not an absolute contraindication, he said.

　　While taking Baycol off the market might be seen as a pre-emptive strike to appease the FDA, it might be a case of closing the proverbial barn door after the horse has escaped. A law firm from Raleigh, North Carolina is soliciting patients on the Internet, inviting patients who have experienced any kind of adverse reaction while taking Baycol to contact the firm for a free legal opinion.
　　Although the law firm does not use the term "class action suit" in its website, it does note that it is already representing clients who have experienced harm as a result of using other drugs including Troglitazone (rezulin), Redux (dexfenfluramine) and Oxycontin.

　　So far, Bayer officials have declined to discuss whether the drug would be re-introduced at a later date, or what will ultimately happen to this statin, which in four short years, captured 8.5 percent of the US statins market.

　　According to financial analysts, Baycol represents approximately $1 billion per year in sales for Bayer.

From:http://www.docguide.com