Baycol (cerivastatin)

Baycol (cerivastatin) is an oral medication used to lower cholesterol and fats in the blood to help prevent heart attacks and strokes. Manufactured by Bayer Pharmaceutical Division, Baycol belongs to a class of drugs called HMG-CoA reductase inhibitors (statins), designed to lower triglycerides (TG) levels in the blood stream.

Why Prescribed

Baycol is a lipid-lowering agent prescribed to reduce bad cholesterol and to reduce the risk of heart disease.

FDA Approved Uses

Baycol was approved for use by the FDA in 1997 to lower bad cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol.

Side Effects

Side effects commonly associated with Baycol include nausea, diarrhea, constipation, headache, and dizziness.

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Warnings and Alerts

The FDA announced on August 8, 2001 that Bayer Pharmaceutical Division was voluntarily withdrawing Baycol from the U.S. market because of reports of fatal rhabdomyolysis, a severe muscle adverse reaction from taking the drug. Prior to this, the FDA had received reports that 31 people died as a result of complications from using Baycol. In every case, the drug caused rhabdomyolysis, where the content of muscle cells spill into the bloodstream and overload the kidneys until they shut down. Other serious side effects associated with Baycol use include liver damage and liver failure.

Drug Contraindications

Baycol is contraindicated in patients who also use gemfibrozil due to the risk of rhabdomyolysis.

FAQ's

What is Rhabdomyolysis?

Rhabdomyolysis is a condition in which muscle cells breakdown and release the contents of muscle cells into the bloodstream. The muscle injury can be so severe that patients develop renal failure and other organ failure, which can be fatal. Fatal rhabdomyolysis has been reported most frequently when Baycol was used at higher doses, used by elderly patients, and particularly when used in combination with gemfibrozil (lopid), another lipid-lowering drug.

How do I know if I have Rhabdomyolysis?

Symptoms of rhabdomyolysis include:

• Muscle pain, weakness, tenderness
• Malaise
• Fever
• Dark urine
• Nausea
• Vomiting

The pain may involve specific groups of muscles or may be generalized throughout the body. Most frequently, the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury or pain.

Are there other lipid-lowering alternatives to Baycol?

Yes, there are five other drugs in the same class (statins) available in the U.S. market. These drugs are Lipitor, Lescol, Mevacor, Pravachol, and Zocor. There are also other drugs approved for lowering cholesterol that are not statins. You should consult you physician to determine which treatment is right for you.

Do other statins present the same safety concerns as Baycol?

All statins have been associated with very rare reports of rhabdomyolysis. These rare cases can occur when the drugs are used alone or in combination with another lipid-lowering drug such as gemfibrozil. However, cases of fatal rhabdomyolysis in association with Baycol use have been reported more frequently than in association with other approved statins.

Can I file a lawsuit if I have been injured as the result of using Baycol?

Patients injured by unsafe products are ordinarily entitled to recover monetary damages for all losses and expenses suffered from use of the product. Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

• Past and future medical expenses
• Past and future pain and suffering
• Lost wages
• Loss of future earning capacity
• Emotional distress

If you have in fact been injured and/or have lost a loved one due to wrongful death from using Baycol, you have legal rights and should contact a qualified defective drug litigation attorney to discuss your legal claim. As all legal claims are subject to time limits, known as statute of limitations, you may risk forfeiture of your right to financial compensation if you delay.