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Petition To Ban Diet Drug Renewed

Sep 3, 2003 | Washington Post

The consumer advocacy group Public Citizen said yesterday the diet drug Meridia has been associated with the deaths of 49 patients since it came on the market five years ago, as the group renewed a petition to the Food and Drug Administration to have the drug banned.

Public Citizen, which initially petitioned the FDA regarding Meridia more than a year ago, supplemented its effort with new information from the FDA "adverse event" database through the end of March. In addition to the 49 deaths, Public Citizen said 124 users have been hospitalized for serious heart and cardiovascular problems since the drug was approved.

"There is no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death," the petition said. Many of the newly reported deaths, the petition said, were of people younger than 50.

Sidney Wolfe, director of Public Citizen's Health Research Group, said he had been told that the FDA is studying whether weight-loss drugs such as Meridia, which contain amphetamine-like compounds, cause more heart and cardiovascular disease than other weight-loss medications.

FDA spokeswoman Laura Bradbard said that after the initial Public Citizen petition, the agency began an additional review comparing adverse event reports for Meridia and for Xenical, another major weight-loss drug that doesn't have amphetamine-like components. She said no date had been set for a decision on the petition.

Meridia's manufacturer, Abbott Laboratories, said the drug is safe and has been used by more than 12 million people worldwide. Fewer than 1 million Meridia prescriptions are written annually in the United States, a company spokeswoman said.

"Sidney Wolfe's supplement to the March 19, 2002, Citizen's Petition to the FDA reflects a pattern of irresponsible conduct by Public Citizen," the company said in a statement. "The safety of Meridia has recently been comprehensively re-examined by regulatory authorities, including the European Committee for Proprietary Medicinal Products and Canadian Health authorities, and [they] have concluded that the risk/benefit profile of Meridia remains favorable. Obese patients are at serious risk for premature death and cardiovascular complications."

Because overweight people have a greater risk of heart attack and cardiovascular disease, the debate now is whether Meridia increases that risk. In its safety information on Meridia, the company says that the drug "substantially increases blood pressure in some patients" but also that weight loss with Meridia can decrease cardiovascular risks.

But Wolfe said, "It's clear this drug increases the risk of death."

Meridia has avid supporters, who say it has helped them lose significant weight. But in its petition, Public Citizen said the average weight loss announced at the drug's approval was 61/2 pounds after a year of taking 10 milligrams daily. The petition also said cardiovascular birth defects were reported in four babies born to women taking the drug.

Last year, the FDA reprimanded Abbott for not properly reporting the deaths of patients taking Meridia. The agency said information about seven deaths was not reported properly, one death was not reported at all and reports on three other deaths were incomplete. Abbott acknowledged the error but said it occurred before it owned the drug, which was developed by Knoll Pharmaceuticals.

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