A review of the published literature and of internal company documents from the manufacturer of cerivastatin, a cholesterol lowering drug removed from the market in 2001, suggests that information about serious adverse effects of this medication was known to the company within months after this drug was launched, and that company analyses showing substantially increased risk of rhabdomyolysis were apparently not published or disseminated to physicians and patients. The article, released early online today because of its relevance to current events, is to be published in the December 1 issue of JAMA.

According to background information in the article, "For medicines that are effective, prompt approval provides rapid access to the health benefits of new drugs. At the same time, U.S. patients are increasingly the first to receive new medications, some of which are subsequently discovered to have serious adverse effects. As a result, the challenge of early detection is increasingly borne by the U.S. postmarketing systems."

Bruce M. Psaty, M.D., Ph.D., from the University of Washington, Seattle, and colleagues conducted a search of the published medical literature and reviewed internal company documents that have become part of the public record during a trial in Nueces County, Texas. The information gathered was used to review the association between the use of cerivastatin sodium (a statin drug removed from the market in 2001) and the risk of rhabdomyolysis (a disorder involving damage to muscle tissue) to illustrate the operation and limitations of the current U.S. postmarketing safety-surveillance system.

"Soon after marketing [of cerivastatin], spontaneous reports identified cases of rhabdomyolysis, an uncommon condition in which the breakdown of skeletal muscle cell causes pain, weakness, and in some cases, renal failure and death," the authors report. "Many but not all of them occurred in cerivastatin users who also took gemfibrozil (a
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Contact: Pam Sowers
206-543-3620
JAMA and Archives Journals
22-Nov-2004

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