On August 8, 2001, Bayer A.G. voluntarily recalled its cholesterol-lowering drug, Baycol® from all world markets except Japan. The recall, which was endorsed by the U.S. Food and Drug Administration, comes after 31 deaths were linked to Baycol®. All of the deaths were reportedly the result of rhabdomyolysis, a severe muscle disorder that can lead to kidney and other organ failure and death. In 12 of the reported 31 deaths, the patients were taking Baycol® along with gemfibrozil, another cholesterol-lowering drug.
Baycol® is marketed worldwide by Bayer and, in the United States, co-marketed by GlaxoSmithKline. Baycol®, also marketed under the name Lipobay®, belongs to a group of cholesterol-lowering drugs known as statins.
Statins, such as Baycol® and Lipobay®, are designed to lower cholesterol levels by inhibiting a liver enzyme that is necessary for the production of cholesterol.
Use of Baycol® and Lipobay®
Baycol® and Lipobay®, generically known as cerivastatin, are prescribed for treatment of hypercholesterolemia, i.e. elevated cholesterol levels, which is a known risk factor for heart attack and coronary artery disease. Baycol® and Lipobay®, along with other medications such as Zocor®, Pravachol®, Lipitor®, and Mevacor®, are known as statins and are commonly prescribed to combat increased blood lipid levels, i.e. high cholesterol.
Each of these medications is prescribed for particular patient-circumstances and all are believed to be effective in lowering cholesterol. Statins such as Baycol® and Lipobay® block a specific liver enzyme that is used in the production of cholesterol. By blocking this enzyme, Baycol® and Lipobay® suppress the body's production of cholesterol. Since statins primarily affect liver function, prescribing physicians generally recommend periodic liver function tests.