Baycol
Generic Name:
Cerivastatin sodium
Brand Names:
Baycol
Baycol Description:
Baycol, manufactured by Bayer A.G. Pharmaceutical, is a cholesterol-lowering drug that is a member of a family of drugs called statins. Baycol is used in the reduction of total and LDL cholesterol in patients who have not properly responded to diet and exercise.
Baycol Uses:
Baycol works by blocking a specific enzyme in the body that synthesizes cholesterol. Studies have shown that Baycol is effective in reducing total cholesterol, triglycerides, and LDL cholesterol, while increasing HDL cholesterol, the good kind of cholesterol.
Baycol is a very effective medication in the family of statins. Statins entered the market in the late 1980s and helped revolutionize the fight against heart disease.
Baycol Interactions:
The following interactions have been noted with Baycol:
- Baycol should be taken at least one hour before bile-acid sequestering agents to keep Baycol from binding to the resin
- Insufficient evidence exists on the safety of taking Baycol in combination with fibrates or nicotinic acid
- Taking gemfibrozil along with Baycol increases your risk of rhabdomyolsis. Of the 31 deaths reported, 12 of the individuals who died were taking gemfibrozil.
The following drugs may interact with Baycol and damage your muscles:
- Cyclosporine (Sandimmune, Neoral)
- Gemfibrozil (Lopid)
- Clofibrate (Atromid-S)
- Fenofibrate (Tricor)
- Niacin (Nicolar, Nicobid, Slo-Niacin)
- Erythromycin (E-Mycin, Ery-Tab)
- Clarithromycin (Sporanox)
- Fluconazole (Diflucan)
- Ketoconazole (Nizoral)
Baycol Dosage Information:
Typical Dosage Recommendation:
Baycol is administered in blister packs of 28 tablets and in adults, should be taken once daily at dinner or bedtime. The initial dose is 0.4 mg taken once daily for 4 weeks. After 4 weeks, dosage may be increased at the discretion of a doctor. Recommended daily doses range from 0.2 mg to 0.8 mg.
Missing a Dose:
If you miss a dose of Baycol, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double doses or you risk overdose. It is important that you finish all pills in your prescription, even if you begin to feel better.
Overdosing:
Seek emergency help as soon as possible if Baycol overdose is suspected. Symptoms of overdose are not known.
Baycol FDA Approval:
Baycol received approval on June 26, 1997, but was withdrawn from the U.S. market on August 9, 2001.
Baycol Recall/Black Box Warning Information:
The FDA has reported that 31 people have died in the United States since 2000 as a result of taking Baycol. Baycol has been known to cause a condition called rhabdomyolsis, a rare and potentially fatal muscle reaction. The cells in the muscles break down and the contents of this breakdown are sent into the bloodstream. Symptoms of rhabdomyolsis include muscle pain, malaise, weakness, tenderness, and dark urine.
In rare instances, organ or renal failure can occur, and this can be fatal. In 29 of the 31 death cases, the patients died of kidney failure. Rhabdomyolsis has been associated with other statin drugs, but the condition was 10 times more common with Baycol.
Back in 1999, Bayer changed the prescribing information to include a contraindication when being co-administered with gemfibrozil. In May 2001, Bayer Corporation again voluntarily changed the prescribing information on Baycol.
As it stands, the Food and Drug Administration (FDA) and the American Heart Association have stated that the risks of taking Baycol and all statins outweigh the benefits.
Baycol was voluntarily pulled from the market by Bayer Pharmaceuticals on August 9, 2001.
Sources:
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July 30, 2010, 2:23 pm
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July 30, 2010, 2:13 pm
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July 29, 2010, 12:33 pm
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July 28, 2010, 3:58 pm
