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Why was Baycol withdrawn from the market?

Why was Baycol withdrawn from the market?


answer for 'Why was Baycol withdrawn from the market?'Baycol (generic name cerivastatin) was withdrawn from the market on August 8, 2001 by Bayer Pharmaceuticals with the support of the Federal Food and Drug Administration (FDA). Bayer voluntarily withdrew Baycol from the market because of 31 reports of death due to a rare, but serious condition called rhabdomyolysis.

Rhabdomyolysis is a condition that involves muscle cell breakdown. As the muscle cells breakdown, their contents are released into the bloodstream. This can cause symptoms such as muscle pain, weakness, tenderness, fever, dark urine, nausea, and vomiting. The muscle pain may be in specific groups of muscles, such as the calves and lower back, or it may be spread throughout the body. Sometimes, the muscle injury is so severe that kidney failure or other organ failure develops, which can lead to death.

Severe cases of rhabdomyolysis with Baycol are rare, but have been reported most frequently with higher doses, when used in elderly patients and in particular, when used in combination with another cholesterol lowering drug called Lopid (gemfibrozil).

Baycol is in a class of cholesterol lowering drugs called "statins". There are five other statins available that may be considered an alternative to Baycol including: Mevacor (lovastatin), >Lescol (fluvastatin), >Pravachol (pravastatin), >Zocor (simvastatin), and >Lipitor (atorvastatin). Contact your doctor about switching to another cholesterol lowering medication.

For more information regarding the withdrawal of Baycol, you may contact the FDA's Drug Information Office at 301-827-4573 or 1-888-INFO-FDA.

Sources:
"Baycol Information," U.S. Food and Drug Administration Drug Information: http://www.fda.gov/cder/drug/infopage/baycol/default.htm Last accessed 11/6/2006.
"Bayer Voluntarily Withdraws Baycol," U.S. Food and Drug Administration Talk Paper: wwww.fda.gov/bbs/topics/ANSWERS/2001/ANS01095.html Last accessed 8/8/01.

This answer prepared 8/8/2001
This information updated 1/23/2007.


Related Links

  • >lovastatin
  • >pravastatin
  • >simvastatin

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