Drug Makers Court Statin Users

Aug. 20, 2001 -- If you're a former Baycol user who has been left stranded, other pharmaceutical companies have a message for you: Try us instead.

Since Bayer was forced to pull its cholesterol-lowering drug from the market two weeks ago, rival companies have been advertising directly to patients who had been taking Baycol.

Bristol-Myers Squibb even offers Baycol users a coupon for a free 30-day trial of Pravachol, its own cholesterol medication.

Besides Baycol, there are five other statin drugs still on the market. Drugs in the statin family significantly reduce cholesterol levels in the body by inhibiting an enzyme that controls cholesterol production, and are the most commonly prescribed cholesterol-lowering drugs in the country.

More Dangerous Than You Might Think

The makers of the other statins would like to convince consumers that their products will not cause the same severe side effects as Baycol.

Baycol was pulled after it was linked to 31 deaths over a three-year period in the United States from rhabdomyolysis, a disorder that causes muscle destruction and can lead to kidney failure.

However, researchers at the health group Public Citizen filed a petition today with the Food and Drug Administration for better warnings on statins, claiming the other five drugs combined have been associated with at least 52 deaths from rhabdomyolysis over the same three-year period as Baycol.

"I think most doctors would believe that we have largely taken care of the problem of rhabdomyolysis … by getting Baycol off the market," says Sidney Wolfe, director of Public Citizen's Health Research Group.

"Baycol is more dangerous than these other drugs. But these other drugs are more dangerous than most doctors and patients realize."

Doctors have been aware for some time that statins can cause rhabdomyolysis, though it was thought to be very rare.

The companies that make these other drugs do warn of the risks in their ads and package inserts, advising patients to "tell your doctor about any muscle pain or weakness you may experience, which may be signs of serious side effects."

Fair Warning

In its petition, Public Citizen researchers called for consistent, bolder warnings to doctors, and clearer, stronger warning letters to patients each time a prescription is filled.

Some health officials, however, do not see the need.

"We have known as physicians for the last decade of these side effects, and we have adjusted our treatment to patients around it," says Richard Stein of the American Heart Association. "Most of us have educated our patients to be aware of these problems."

An FDA official said the agency is still analyzing reports of adverse reactions to the five cholesterol-lowering drugs, and that no labeling changes would be made until that review has been completed.

— ABCNEWS' John McKenzie contributed to this report.