Knowledge Means Power

Baycol

On Aug. 8, 2001, after only four years on the market, the manufacturer of Baycol, Bayer A.G., pulled it from the U.S. market. At its peak some 12 million people were taking Baycol (also known as Lipobay, Cholstat or Cerivastatin). During its short life, Baycol had become the most popular among a new and highly effective class of cholesterol-lowering drugs called “statins”. Statins work by blocking a liver enzyme associated with the production of cholesterol.

The Dangers of Baycol

Baycol was connected with deaths due associated with rhabdomyolysis, a muscle disorder that can cause renal failure. The Food and Drug Administration said testing showed a clear link between the drug and the disease. Rhabdomyolysis destroys muscle cells and releases byproducts into the bloodstream, which can damage the kidneys and lead to possible renal failure.

The condition is more likely to be found in the elderly who took higher doses of Baycol (also called Lipobay when sold in other countries) and those who took Baycol in combination with another drug, gemfibrozil (or Lopid by brand name).

Am I in Danger?

Symptoms of rhabdomyolysis include dark or brown colored urine, muscle tenderness, weakness, fever, nausea, vomiting and general malaise. Pain from the disease can be generalized throughout the body or involve specific muscle groups, often in the lower back and calves.

Questions and Answers about Baycol from the FDA:

1. What should I do if I am taking Baycol?

If you are taking Baycol, contact your physician to discuss alternative medications. If you are taking Baycol and experience muscle pain, discontinue Baycol immediately and contact your physician for further advice.

2. What should I do if I am taking Baycol and gemfibrozil (Lopid)?

If you are taking Baycol and gemfibrozil (LOPID), discontinue the Baycol immediately and contact your physician for further advice.

3. What is rhabdomyolysis?

Rhabdomyolysis is a very rare condition where serious muscle damage results in release of muscle cell contents into the bloodstream. On very rare instances, rhabdomyolysis may result in kidney damage and other organ damage which may be fatal.

4. How do I know if I am having this serious reaction (rhabdomyolysis) to Baycol?

Patients who develop rhabdomyolysis often have muscle aches involving their calves, back, or their entire body. The pain may be accompanied by weakness, fever, nausea, vomiting, and passing of dark urine.

5. What should I do if I think I’m having this reaction (rhabdomyolysis) to Baycol?

Stop the drug immediately and call your physician.

6. What is Baycol used for?

Baycol is a cholesterol-lowering drug belonging to a class of drugs known as “statins”. It is prescribed to reduce your cholesterol and to reduce your risk of heart disease.

7. Will I have any problems if I stop Baycol?

If you were prescribed Baycol to lower your cholesterol, these levels may go back to where they were before you received the drug. These changes will not occur immediately but will most likely occur over a couple of days to weeks. If you stop Baycol, be sure to consult your physician to discuss alternative therapies for lowering your cholesterol.

8. Are there any alternatives to Baycol?

There are five (5) other drugs in the same class (statins) available in the U.S. market. They are atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor). There are also other drugs approved for lowering cholesterol that are not statin drugs. You should consult you physician to determine which treatment is right for you.

9. Do the other statins have 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 other approved statins.

Posted: Aug 31 2009, 03:45 PM by digitalangel | with no comments
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