Cerivastatin sodium or "Baycol" is a synthetic pharmaceutical that belongs to a class of drugs called statins. Unlike the other statins, Baycol use frequently leads to a condition called rhabdomyolysis that has caused more than one hundred deaths and hundreds of serious injuries. Baycol is designed to inhibit an enzyme in liver cells that produces potentially harmful low-density lipoprotein (LDL) cholesterol and triglycerides. When that process is partially blocked, a cell produces substantially less cholesterol. In addition to dietary therapy and exercise other therapies for hypercholesterolemia include bile acid sequestants, niacin and fibric acid derivatives.

The U.S. Food and Drug Administration ("FDA") approved Baycol manufacturer Bayer Corporation's application to sell the drug in 1997. The drug was first marketed in .2 mg and .3 mg strengths. In 1999 the FDA approved .4 mg. strength tablets and a year later allowed Bayer to put.8 mg strength tablets on the market. On August 8, 2001, the FDA announced a recall of Baycol due to the serious health complications. According to the announcement, Bayer Corporation would immediately remove Baycol from the market. The FDA cited to 32 deaths in the United States and 20 abroad attributed to Baycol-induced rhabdomyolysis. The numbers have risen steadily since the announcement.

Baycol differs from other statins in a number of important ways. The original statins are derived from fungi, as are drugs like penicillin. Baycol is synthesized, that is, wholly man-made. The other statins are generally less potent than Baycol, but equally of more effective. The other statins include fluvastatin (Lescol), lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), atorvastatin (Lipitor), mevastatin, colesevelam and rosuvastatin.

Users of Baycol are far more likely than users of other statins to experience muscle cell damage or rhabdomyolysis. Rhabdomyolysis is a potentially fatal condition that occurs when skeletal muscle dies releasing intracellular protein into the plasma and bloodstream. Rhabdomyolysis is frequently followed by a collapse of kidney function. Symptoms include abnormal, dark, red or cola colored urine, muscle stiffness, tenderness or aching, nausea or generalized weakness and fatigue.

Those most vulnerable to Baycol complications include patients taking high doses of the drug, elderly users, and those taking Baycol in combination with gemfibrozil, another cholesterol drug sold under the trade name "Lopid". Symptoms of rhabdomyolysis include unusual fatigue, muscle pain, body weakness, dark urine, fever, nausea and vomiting.

If you or a family member has suffered in injury as a result of Baycol, we can help. Call Mark A. Hunt & Associates today to set up an appointment.