Meridia Diet Drug Pulled from US Market: FDA

October 15, 2010, 8:00AM. By Gordon Gibb

Washington, DCThe manufacturer of Meridia sibutramine has finally decided to pull the diet drug from the market after failing to win the approval of a safety advisory panel affiliated with the US Food and Drug Administration (FDA). The latter actually requested that Abbott Laboratories withdraw the drug, to which Abbott complied.

However, the withdrawal comes way too late for Dr. Sidney Wolfe of the consumer advocacy group Public Citizen. It was almost a year ago, in December of 2009, that Wolfe re-submitted a petition to the FDA in an effort have the diet drug banned. While it's no surprise that Wolfe is happy to see the drug go, he is nonetheless critical of the FDA for waiting too long due to the potential for Meridia side effects.

"The FDA's decision to ask Abbott to withdraw the drug is commendable but dangerously too late for all of the victims of its unacceptable risks," said Wolfe, in comments appearing October 9th in the Los Angeles Times. It should be noted that Public Citizen originally campaigned for a ban of Meridia in 2002.

Wolfe noted that the European Medicines Agency took steps to ban Meridia in the European community in January, citing the same evidence the FDA used to foster a removal of the drug in the US some ten months later.

Two of 16 participants in an FDA advisory panel noted that the diet drug, which has been on the market since 1997, should carry a boxed warning for Meridia heart attack. Six of the panelists said the drug should be prescribed only by "specially trained physicians" and should include a strict FDA black box warning noting the new limits. Eight of the 16 panelists said Meridia should be withdrawn from the US market outright.

"Meridia's continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said Dr. John Jenkins, director of the FDA's Office of New Drugs in the agency's Center for Drug Evaluation and Research, in comments appearing in the Los Angeles Times.

A statement by the manufacturer of Meridia, Abbott Laboratories, was brief and made no reference to Meridia stroke or other Meridia side effects. Abbott said it "believes [Meridia] has a positive risk/benefit profile in the approved patient population but will comply with the FDA's request."

Abbott is reported to have pulled back on the promotion and marketing of Meridia sibutramine in the US amidst the controversy over risk for heart attack. Even so, sales of the once-popular diet drug are projected to be $30 million in the US this year. On the same day as the Meridia FDA announcement on October 8th, the federal regulatory body warned consumers against another product—Slimming Beauty Bitter Orange Slimming Capsules—due to its active ingredient, sibutramine.