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Bayer Pulls Cholesterol Drug Tied to 31 Deaths

Baycol can cause muscle destruction

WEDNESDAY, Aug. 8, 2001 (HealthDayNews) -- Bayer Corp. is pulling its cholesterol-lowering compound Baycol, which health officials say has been linked to at least 31 deaths in the United States.

Bayer and the U.S. Food and Drug Administration (FDA) say Baycol, a member of the statin family of medications approved in 1997, can trigger occasionally fatal cases of rhabdomyolysis, in which the body destroys its muscles. Each of the five other statins on the market slightly increases this risk, but Baycol, or cerivastatin, does so much more seriously, health officials say.

The FDA says patients on Baycol should talk with their doctor about switching to one of the other statins on the market. Those experiencing muscle problems, or who are also taking gemfibrozil, a cholesterol-dropping drug, should stop using Baycol immediately.

Rhabdomyolysis is a rare condition that causes muscle cells to break down and discharge their contents into the bloodstream. Symptoms can include painful, tender or weak muscles; fever; malaise; nausea; vomiting, and abnormally dark urine.

Although the malady typically affects the calves and lower back, it can strike muscle groups throughout the body. In extremely severe cases, the breakdown leads to failure of the kidneys and other organs, which in turn can be deadly.

Of the 31 patients on Baycol who died, 12 were also taking gemfibrozil, which in combination with other lipid-lowering compounds has been shown to raise the risk of muscle pain and swelling.

Officials at Bayer did not return calls seeking comment on the recall, which will cover every country in which the drug is sold except Japan. (In Japan, available doses are lower and gemfibrozil isn't on the market.)

"We have decided on this action in the interest of patient safety," Dr. David Ebsworth, manager of Bayer's Pharmaceuticals Business Group, says in a statement. "We will continue to conduct further assessments over the next few months to evaluate the benefit/risk ratio of cerivastatin."

Dr. Sidney Wolfe, of the consumer group Public Citizen, calls the notion that Japanese patients will be protected from harm "preposterous."

More than half the Baycol patients in the United States weren't taking a high dose, nor were they taking gemfibrozil, says Wolfe, whose group intends to recommend that the Japanese government ban the drug entirely.

Public Citizen had been preparing to petition the FDA to strengthen the warning labels on all statins when the Bayer recall was announced, Wolfe says, and it plans to continue its campaign. The group will also ask the FDA to publish a medication guide for statin users that would encourage them to pay close attention to muscle symptoms before they become severe.

Wolfe says "several hundred" patients on Baycol suffered non-fatal cases of rhabdomyolysis, and there are "hundreds of cases of [the condition] with the other statins collectively."

The FDA has considered making statins available without a prescription. Earlier this year, the National Institutes of Health declared that statins are widely underused in this country, and that the number of Americans taking the drugs to lower their cholesterol should triple, from about 13 million to 36 million.

"At this point, FDA has not considered changing the labels of other statins. It should be emphasized that all approved statins already have warnings of rhabdomyolysis for the monotherapy use of the statin and its combined use with gemfibrozil," Crystal Rice, an FDA spokeswoman, says in an e-mail interview. "Obviously, the risk of rhabdomyolysis carried by a particular statin, and whether the consumer can follow instructions and avoid being at greater risk for rhabdomyolysis, will need to be considered in this review process."

Reducing low-density lipoprotein (LDL), the "bad" form of cholesterol, can cut the near-term risk of heart disease by 40 percent, and perhaps by even more over a decade, experts say.

What To Do

For more on the recall, or if you have any questions about Baycol, try the Food and Drug Administration or call Bayer toll-free at 1-800-758-9794.

To learn more about high cholesterol and how to keep it in check, visit the American Heart Association or the National Institutes of Health.

SOURCES: Interviews with Sidney Wolfe, M.D., director, Public Citizen's Health Research Group, Washington, D.C.; Crystal Rice, spokeswoman, U.S. Food and Drug Administration; FDA, Bayer Corp. statements
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