Bayer Pulls Its Cholesterol-Lowering Drug Baycol Off Market

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Friday, April 12, 2002 11:10 AM

Bayer Pulls Its Cholesterol-Lowering Drug Baycol

Off Market

 

 

webmd.com/drug_article/article/4048.101

 

 

 

 

Bayer Pulls Its Cholesterol-Lowering Drug Baycol Off the Market

Reviewed by Dr. Dominique S. Walton

 

 

On Aug. 8, 2001, the FDA announced that drugmaker Bayer pulled its

cholesterol-lowering drug Baycol off the market because of 31 deaths connected

to its use.

 

 

The patients died from a severe side-effect called rhabdomyolysis, where the

muscles in the body can break down, releasing proteins and chemicals into the

bloodstream that overwhelm the kidneys and cause them to shut down.

 

 

Rhabdomyolysis has been seen in the five other cholesterol-lowering drugs,

collectively called " statins, " which cut down the body's cholesterol production

by blocking an enzyme called HMG-CoA. But the rates of this complication were

much higher in patients who were taking Baycol alone or a combination of Baycol

with another lipid-lowering drug called Lopid. (Its generic name is

gemfibrozil).

 

 

In past warnings, Bayer had informed doctors of the risk of the complication

when Lopid and Baycol were used together. But even after the warnings, the cases

of rhabdomyolysis continued, and the company chose to withdraw the drug from the

market.

 

 

Symptoms of rhabdomyolysis include muscle pain, weakness, fever, dark urine,

nausea, and vomiting. It affects the muscles in the calves and the lower back

most often, but the FDA says some patients with this side-effect report no

symptoms.

 

 

What to Do:

 

 

The FDA says that if you are experiencing muscle pain or are also taking Lopid,

stop taking Baycol immediately and consult your physician.

 

 

Doctors say that statin therapy is still very important in patients who need

medication to control their high cholesterol and lessen their risk of

cardiovascular disease. This report should not turn people away from statin

therapy in general.

 

 

But if you have been taking Baycol, you need to talk to your doctor about

finding another statin that would work well for you, as well as assess your risk

of rhabdomyolysis while you have been taking Bayer's cholesterol drug.

 

 

For more information, read a WebMD news article on this drug withdrawal as well

as an FDA release.