Cholesterol Drugs Need Stronger Warning, Consumer Group Says

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Aug. 17, 2001 (Washington) -- In light of the cholesterol-lowering drug Baycol being pulled off the market after it was linked to 31 deaths, the consumer advocacy group Public Citizen plans to urge the FDA to place a stronger warning label on five similar drugs that are still available.

Sidney Wolfe, MD, director of Public Citizen's Health Research Group, tells WebMD that his organization has identified from an FDA database 50 additional deaths due to statins, the class of drugs to which Baycol belongs.

The labels of statins currently carry a bold print warning about the risk of a side effect known as rhabdomyolysis or the breaking down of muscle, which was the cause of the 31 deaths attributed to Baycol.

But Public Citizen wants a stronger warning because fatal rhabdomyolysis happens with all the statins and there's probably more than 50 deaths associated with the drugs, Wolfe says.

Public Citizen plans to file a citizen's petition with the FDA next week arguing that the additional deaths should prompt the agency to place a black box warning, the strongest warning, on the label of all the statins, Wolfe says.

The FDA, however, does not believe this side effect is a big concern with the other statins. "There was a huge difference in the amount of cases of rhabdomyolysis with Baycol as compared with the other statins," agency spokeswoman Laura Bradbard tells WebMD.

The withdrawal "had nothing to do with the statins" as a class, she says. This seems to be something unique to Baycol, and "we don't understand why."

Rhabdomyolysis is a "very rare" side effect, and "most physicians will never see an episode in their careers," Bradbard notes.

Patients should see their doctors about switching off of Baycol, Sidney Smith, MD, the chief science officer of the American Heart Association, tells WebMD.

But if they are already on another statin and "do not have muscle ache or dark urine or other symptoms [indicative of rhabdomyolysis], I would encourage them to stay on their statin," says Smith, who also serves as the director of the center for cardiovascular science and medicine at the University of North Carolina at Chapel Hill.

Public Citizen may be misinterpreting the reports of deaths associated with the statins, some feel. Bradbard notes that all deaths, even if they are not due to the drug, get reported initially. Then the agency reviews the cases and determines if the drug was to blame. Most cases do not end up being due to the drug, so few, if any, of these 50 additional deaths will ultimately be linked to the statins, Bradbard says.

The agency would not immediately release to WebMD the number of deaths that have been reported with the statin drugs, but the manufacturers claim that few deaths have been associated with their drugs.

Ten deaths have been associated with Pfizer's statin Lipitor, company spokeswoman Vanessa McGowan tells WebMD. This is a relatively low rate considering that millions more people use Lipitor than use each of the other statins, including Baycol, according to figures from IMS Health.

Lipitor has a "good safety ... profile," and "we don't expect to have to change our labeling," McGown says.

No deaths due to rhabdomyolysis have been associated with Bristol Myers Squibb's statin Pravachol, company spokeswoman Bonnie Jacobs tells WebMD.

Merck would not disclose the exact number of deaths that have occurred with its two statins Mevacor and Zocor. But spokeswoman Donna Cary tells WebMD, "I'm not going to say that there haven't been any deaths."

Merck feels the black box warning is too strong for a side effect that occurs so rarely, Cary says. She notes that the warning about rhabdomyolysis is "clearly spelled out and it's in bold type" on the label. "Sid Wolfe's group wants a black box warning for everything," she adds.

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