FDA urged to pull diet drug from shelves

WASHINGTON, Sept. 2 (UPI) -- The U.S. Food and Drug Administration is being urged to take a diet drug off the market because it allegedly raises the risk of heart attack, officials said.

A study and an accompanying editorial in the New England Journal of Medicine Wednesday says the risks presented by the prescription diet drug sibutramine, sold under the brand name Meridia, outweigh the modest benefits of the medication, the Chicago Tribune reported.

The study, first published on a U.S. government clinical trials Web site, showed sibutramine increased rates of non-fatal heart attacks and strokes in people with a history of cardiovascular disease who took the medication for an average of 3.4 years.

Based on the study data, the drug was withdrawn in Europe earlier this year.

The FDA says it will hold hearings this month to reconsider the drug's safety.

"Sibutramine doesn't help people," New England Journal of Medicine Executive Editor Dr. Gregory Curfman said. "It doesn't result in very much weight loss, and it doesn't improve their clinical condition. On the other side, it carries these risks."

Approved in 1997, the medication works by altering levels of chemicals in the brain to decrease appetite. The drug is known to increase blood pressure and heart rate, and carries a warning that it should not be used in patients with heart disease and should not be taken for more than two years.