FDA Denies Petition To Remove Weight-Loss Medication Meridia From Market
FDA has denied a petition from Public Citizen to remove Abbott Laboratories' prescription weight-loss drug Meridia from the market, Abbott and Public Citizen said on Tuesday, the Chicago Tribune reports. The consumer group filed its complaint against Illinois-based Abbott's drug three years ago, alleging that Meridia was a factor in dozens of deaths and more than 400 adverse patient reactions since it reached the market in 1997.
FDA approved Meridia after an agency advisory panel in 1996 voted 5-4 against the drug. The drug "has been shown to elevate blood pressure in patients, something Abbott says is clearly spelled out on the FDA-approved label," the Tribune reports.
David Graham, FDA's drug safety officer, in 2004 testified before a Senate panel that Meridia was one of five potentially dangerous drugs that the agency should review. Graham's testimony came as lawmakers first began to consider how FDA could improve its monitoring of drug safety in the wake of the Vioxx recall, according to the Tribune.
FDA has been working with Abbott to improve instructions on proper usage of the drug. Abbott, which acquired Meridia in 2001, on Tuesday said that earlier this year it implemented a program to reinforce Meridia's appropriate uses, including an "educational outreach" program for physicians.
John Leonard, Abbott's vice president of global medical affairs, said FDA's decision was "good news for obese patients and their physicians who are considering pharmacotherapy who may have been alarmed by Public Citizen."
Abbott in a statement said the drug, which has about $300 million in annual sales, is safe and effective "for people who need to lose 30 pounds or more depending on height" and "when combined with diet and exercise."
However, Sidney Wolfe, director of Public Citizen's Health Research Group, said, "A lot of the people who died from this were very young, in their 20s, 30s and 40s. It is very difficult for the FDA to admit they made mistakes" (Japsen, Chicago Tribune, 8/17).