- The Washington Times - Friday, August 10, 2001

Cerivastatin, a popular cholesterol-lowering drug voluntarily withdrawn from the market after the deaths of 31 patients, is in a class of drugs called statins that transformed cholesterol treatment when the first of its kind was approved in 1987.

Cerivastatin was taken off the market Wednesday.

Statins have been associated with drops in total cholesterol as high as 50 percent. But they've also been associated with a complication involving muscle breakdown, which can lead to kidney failure and death.

In a discussion paper, the U.S. Food and Drug Administration (FDA) acknowledged "all statins" have been linked to "very rare reports" of this muscle condition known as rhabdomyolysis.

But the agency pointed out that cases of fatal rhabdomyolysis have been "reported significantly more frequently" with the use of cerivastatin, also known as Baycol, than with any of the other five statin drugs currently approved for use in the United States.

John Jenkins, director of the FDA's office of drug evaluation, said in numerous interviews that the agency has received at least 10 times more complaints about severe complications, including death, in connection with Baycol than any other statin drug.

On Wednesday, the FDA announced that the maker of Baycol, now taken by some 700,000 Americans, is voluntarily pulling the drug from the market. "The FDA agrees with and supports this decision" by Bayer AG, the German firm that makes cerivastatin.

The FDA said the five other statins available in the United States "may be considered as alternatives to Baycol." But it cautioned patients now taking Baycol to consult with their doctors about switching to other medications.

The other five statins are lovastatin (Mevacor), which was the first drug in its class to be approved; pravastatin (Pravachol); simvastatin (Zocor); fluvastatin (Lescol); and atorvastatin (Lipitor). About 12 million Americans take drugs classified as statins.

"Statins inhibit an enzyme from producing cholesterol, and they are very effective in lowering a harmful form of cholesterol known as LDL [low-density lipoprotein]," said Paul MacCarthy, vice president of medical sciences for Bayer's U.S. operations.

Lovastatin, the first statin drug, became an overnight success 14 years ago when the FDA approved it and said it had reduced cholesterol levels by 25 percent in clinical trials.

"Statins lower cholesterol and lower the incidence of heart disease. Statins have some adverse events, but those are very rare, and the benefits from statins outweigh" the risks, FDA spokeswoman Laura Bradbard said yesterday.

But she said the FDA supports the withdrawal of Baycol, since that drug "does not have benefits that outweigh the other statins" that can still be obtained.

As for the rhabdomyolysis that some patients on statins develop, Miss Bradbard said, "This is an adverse event, which, across the class, is very rare. It is generally not fatal."

She added: "We don't know why this happens or why the risk is much greater with Baycol" than with other statin drugs.

Rhabdomyolysis can lead to kidney failure, as poisons released from dissolving muscle tissue inundate the bloodstream. According to FDA officials, 29 of the 31 patients on Baycol who died suffered kidney failure.

Statins have also been known to have other health side effects.

Dr. Patricia Davidson, a cardiologist at the Washington Hospital Center, said, "I've always monitored statins closely" because of concerns about liver damage from overuse.

"You just don't know if people taking statins will go for blood tests" to check liver enzyme levels.

Dr. Davidson said the two most recently approved statins — Baycol and Lipitor — have not been the subject of the same kind of randomized international testing as the other statin drugs. "But we're forced to use Lipitor, since it's the strongest, and I've seen minor complications, such as leg cramps" in some patients, she said.

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