The cholesterol-lowering drug, Baycol, has been linked to Rhabdomyolysis, a severe adverse muscle reaction, which has caused 31 deaths.

Baycol, manufactured by the Bayer Pharmaceutical Division, is classified as a statin, drugs which block the enzymes in the body that produce cholesterol.

Even though all statins have been associated with Rhabdomyolysis, the FDA granted approval of Baycol in 1997. And, doctors continue to prescribe it; despite the numerous reports that show cholesterol levels can usually be lowered through proper diet, without the need for drugs.

According to Public Citizen, a consumer advocacy group, statins have been responsible for 50 other deaths in the United States, warranting the need for stronger warning labels. The FDA does not plan to review Baycol or other statins.

Rhabdomyolysis is a condition that results in muscle cell breakdown and releases cell content into the bloodstream.

Symptoms include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting.

Pain from Rhabdomyolysis may involve specific muscles, usually the calves or lower back, or may spread throughout the body, targeting all muscle groups.

Rare cases have been reported, in which the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.

After 31 reports of deaths linked to Baycol were sent to Bayer, the company “voluntarily” withdrew the drug from the market.

SOURCE: “Cholesterol drug linked to 31 deaths,” Health Watch newsletter, www.wcanews.com, August 2001.