Cholesterol Drug Pulled From Market

Aug. 8, 2001 -- Drug maker Bayer pulled its popular cholesterol-lowering medication off the market today amid reports of a deadly side effect.

According to the Food and Drug Administration., Bayer Pharmaceuticals voluntarily withdrew Baycol, known generically as cerivastatin, as a result of the 31 patients deaths associated with the drug over the last four years.

The drug's rare side effect, rhabdomyolysis, destroys muscle cells then releases them into the bloodstream and can cause severe muscle pain, frequently in the calves or lower back. In rare instances the effects are so severe, patients develop potentially fatal kidney or other organ failure.

Symptoms of the condition include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting.

Particular Risks

Approved in 1997, Baycol is part of a class of cholesterol-lowering drugs called statins. Experts say rhabdomyolysis is a known side-effect of all statins.

According to Paul Doering of the University of Florida's College of Pharmacy, the drugs have remained on the market because "the positive benefits of the drug outweigh the rare frequency of occurrence."

But Baycol stands out because it has caused a significantly higher number of reported deaths, especially when used in high doses, in elderly patients, and particularly when combined with another cholesterol-lowering drug called gemfibrozil, also known as LOPID.

Doering blames the FDA's approval process for today's recall: "This recall highlights a broader problem, and that is the inability of the drug approval process to predict what the true nature of any drug is, based solely on the data required for an NDA [new drug application].

"It has taken this long for enough data to accumulate for the FDA to finally drop the ax. This begs the question: What is the threshold after which the benefits no longer outweigh the risks? The answer, of course, would depend on the drug and the disease which it treats."

Other Drugs Called Safer

According to Lisa Stump, associate director of pharmacy services at Yale-New Haven Hospital, "rhabdomyolysis was not reported in clinical trials with Baycol, but case reports appeared in the literature after the drug was marketed."

There are five other companies that make cholestoral lowering drugs and 13 million Americans who take them.

Doering predicts "other companies making competing products are shaking in their collective boots right now."

But Merck spokeswoman Donna Kary disagrees. She says no deaths have been associated with the company's popular statin drug Zocor.

However, warning labels about the condition are "in the literature, it's known, and we carry information about it in our label. But we haven't seen any problems associated with this."

Statins Called Generally Safe

Experts warn patients not to overreact to the recall.

"My primary concern is that patients will stop taking all statins because of fears about the safety of statins. The other statins such as Zocor and Pravachol have been shown to be safe and efficacious in excellent large outcome studies," says Dr. Colleen Conroy, vice chair of Colorado Health Sciences University.

The FDA advises patients who are taking Baycol to contact their doctors about switching to a different drug.

Experts were not immediately clear on why Baycol would differ in danger from other statins, but conjectured that it may combine differently with other drugs.