DESCRIPTION: Bayer Pharmaceuticals introduced "Baycol" to the American market in 1999. At the urging of the Food and Drug Administration, Bayer removed Baycol from the market on August 8, 2001, following reports of fifty-two deaths to the FDA. Of those, 12 deaths occurred when patients used Baycol in combination with gemfibrozil (lopid), another cholesterol-lowering drug.

Baycol is in a class of drugs called, "statins." Physicians prescribed Baycol and other statins to treat high cholesterol. There are five other statins presently on the market. These are safer alternatives, as only Baycol has been removed because of the potential hazards to its users.

The major side effect of Baycol ingestion is rhabdomyolysis, a disease characterized by a breakdown and release of the contents of muscle cells into the bloodstream. As a result, injury to the kidney occurs because of the toxic effects of the contents of muscle cells. This condition may be fatal, or may be non-fatal but cause kidney failure, liver injury, seizures, joint and muscle pain, and fatigue for the rest of the patient's life. In addition, patients who develop rhabdomyolysis often have muscle aches involving their calves, back, or their entire body. The pain may be accompanied by weakness, fever, nausea, vomiting, and passing of dark urine. As of this writing, a total of 3,500 cases of rhabdomyolosis have been reported to the FDA for all drugs since the beginning of adverse event reporting. Of these, 500 have been attributed to Baycol.

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Last modified: 10/08/02