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Orange Arrow Bayer Voluntarily Withdraws Baycol
Orange Arrow FDA Recall & Safety Alerts
Orange Arrow Center for Drug Evaluation & Research

Baycol Frequently Asked Questions
Information provided by FDA/Center for Drug Evaluation and Research
Always consult a pysician regarding any medical matters.
Last Updated: August 08, 2001

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, the Center for Drug Evaluation & Research advises that you 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), the Center for Drug Evaluation & Research advises that you discontinue the Baycol immediately and contact your physician for further advice.

3. What is rhabdomyolysis ?

According to the Center for Drug Evaluation & Research, 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 ?

According to the Center for Drug Evaluation & Research, 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 ?

The Center for Drug Evaluation & Research advises that you stop taking 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 ?

According to the Center for Drug Evaluation & Research, 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 ?

According to the Center for Drug Evaluation & Research, 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.

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