Statin, Baycol, and Rhabdomyolysis Questions

On August 8, 2001, Baycol was taken off the market. The FDA provided questions and answers about Baycol, the statin drug intended to lower cholesterol for the 700,000 Americans taking Baycol at that time. Baycol side effects include the serious and potentially fatal condition rhabdomyolysis.

CONTENTS

What should I do if I am taking Baycol?
What should I do if I am taking Baycol and gemfibrozil (Lopid)?
What is rhabdomyolysis?
How do I know if I am having this serious reaction (rhabdomyolysis) to Baycol?
What should I do if I think I’m having this reaction (rhabdomyolysis) to Baycol?
What is Baycol used for?
Will I have any problems if I stop Baycol?
Are there any alternatives to Baycol?
Do the other statins have the same safety concerns as Baycol?
Who can I contact for more information on Baycol?



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.

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.

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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.

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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. Weakness, fever, nausea, vomiting, and passing of dark urine may accompany the pain.

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What should I do if I think I’m having this reaction (rhabdomyolysis) to Baycol?
Stop the drug immediately and call your physician.

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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.

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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.

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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.

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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.

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Who can I contact for more information on Baycol?
Please contact us if you would like to receive more information on Baycol side effects.

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