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BMJ. Mar 8, 2003; 326(7388): 518.
PMCID: PMC1169279

Bayer is forced to release documents over withdrawal of cerivastatin

Pharmaceutical giant Bayer has, for the first time, been forced to release confidential company documents to the US courts in a damages case over the lipid lowering drug cerivastatin. The case, held in a Texan court, reveals just how much the company knew about the problems with the drug before withdrawing it in 2001.

Bayer withdrew cerivastatin (marketed as Baycol in the United States and Lipobay in Europe) from the US market and Europe in August 2001 and subsequently in Japan because of an increasing number of reports to the US Food and Drug Administration of rhabdomyolysis—a rare disorder in which muscle tissue breaks down and that can lead to organ failure and death—in patients who took the drug.

Until now suits for damages filed by patients who had been taking the drug had been met by Bayer with settlements out of court. At least 7800 product liability suits have been filed against Bayer and its British marketing partner, GlaxoSmithKline. About 450 suits have been settled for sums ranging from $200 000 (£127 000; €185 000) to $1.2m, according to patients' lawyers. In many instances plaintiffs experienced no side effects. But Bayer says that 100 deaths and 1600 injuries have been linked to use of the drug and that 700 000 Americans and some six million patients worldwide used the drug.

Now, with the opening of the trial in Texas last week, for the first time the issue is in open court—and with this comes the public release of documents leading up to the August 2001 decision to withdraw the drug from the market. The court is hearing a suit brought by a patient who developed rhabdomyolysis after taking the drug. At Bayer's request many of these documents remain sealed, but the plaintiff's lawyers, arguing for punitive damages in addition to compensation, are introducing some in court.

The plaintiff's lawyers argue that these documents show that Bayer was aware of problems associated with Baycol since its approval by the FDA in 1997. However, occasional adverse reactions often occur with a new drug, and although these may be of concern they are not necessarily grounds for withdrawal. More serious is a suggestion that not all adverse events were reported to the FDA, but Bayer says it kept the FDA fully informed.

Complicating the issue is that some doctors prescribed cerivastatin along with another lipid lowering drug, gemfibrozil, despite a warning from the company that this could result in adverse reactions. A further complication is that in July 2000 the FDA approved a doubling of the dose of the drug from 0.4 to 0.8 mg, because of a lack of efficacy at the lower dose. By the spring of 2001 the FDA noted a sudden increase in reports of adverse reactions with the drug. This prompted discussions with Bayer and resulted in the company's decision to withdraw cerivastatin from the market in August 2001. At the time 31 deaths were linked to the drug, 12 of them among patients taking it at the higher dose, according to the FDA.

Statins are considered the first line of treatment for most patients with a high serum cholesterol concentration. Statins block hydroxymethyl glutaryl coenzyme A reductase, an enzyme involved in the synthesis of cholesterol. There are five other statins on the US market, besides cerivastatin. The FDA says that although the statins have been associated with cases of rhabdomyolysis, cerivastatin was associated with significantly more deaths.

Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Group
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