Anti-Cholesterol Drug Deaths

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Baycol The FDA announced on August 8, 2001 that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision. Symptoms of rhabdomyolysis include the following:

 

muscle pain,

weakness

tenderness

fever

dark urine

nausea and vomiting.

Questions and Answers about Baycol(From FDA/Center for Drug Evaluation and Research)

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.

IN THE NEWSAugust 8, 2001Bayer Pulls Anti-Cholesterol DrugBy THE ASSOCIATED PRESSFiled at 10:26 a.m. ET

WASHINGTON (AP) -- One of the popular cholesterol-lowering medicines called statins -- Bayer Pharmaceutical's Baycol -- was pulled off the market Wednesday because of muscle destruction linked to 31 U.S. deaths.

At issue is a side effect called rhabdomyolysis, an acute condition in which muscle cells are destroyed and released into the bloodstream. It can cause severe muscle pain, most frequently in the calves and lower back - and occasionally the condition is so severe that patients develop potentially fatal kidney or other organ failure.

All the extraordinarily popular anti-cholesterol drugs called statins have been linked to very rare reports of rhabdomyolysis. But the Food and Drug Administration said Wednesday that Baycol has been linked to significantly more fatal cases than its competitors -- 31 deaths that FDA knows about since Baycol was approved for U.S. sale in 1997.

Working with FDA, Bayer voluntarily pulled the drug, also known as cerivastatin, off the market Wednesday.

The FDA said the Baycol side effect was reported most frequently when the drug is used by the elderly, at higher doses, and especially when it's used together with another cholesterol medicine called emfibrozil. In 12 of the 31 U.S. deaths, patients were taking both of the drugs together.

The FDA said patients who are taking Baycol should call their doctors about switching to a different cholesterol medicine, including any of five other statins.

Anyone taking Baycol who experiences muscle pain and is also taking gemfibrozil should immediately stop the Baycol and call a doctor, the FDA said. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting.

If you or a family member have been injured by Baycol and would like an experienced attorney to investigate your claim, contact Davis & Feder at 1-866-857-8400.

For more news articles on Baycol click one of the links below

The Washington Post

Associated Press