Abbott Labs agrees to pull its obesity drug Meridia off US and other markets

US health care major Abbott Laboratories (NYSE: ABT) has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the US market because of clinical trial data indicating an increased risk of heart attack and stroke, the Food and Drug Administration announced last Friday.

Abbott said it also withdrew Meridia in Australia and Canada. The drug remains on the market in 40 countries, mostly in Asia and Latin America, but the company is discussing the drug's future with regulators in those countries The drug has seen falling sales because of safety concerns and for the first half of this year brought in just $80 million in sales worldwide, of which $20 million was in the USA. The drug was pulled in Europe - where it was marketed as Reductil - in January after a study found 16% more major cardiovascular side effects among almost 10,000 high-risk patients who were followed as long as six years (The Pharma Letter January 22).

Meridia’s safety has been under scrutiny for a while, and just last month was the subject of an FDA advisory panel review. The Endocrinologic and Metabolic Drugs Advisory Committee reviewed the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and sibutramine (sold as Meridia in the USA). The investigation ended with a split, eight to eight, vote, with six panelists recommending a new boxed warning and restricted distribution of Meridia, and two voting that a boxed warning alone would be sufficient. No panellists voted for an option that called for no changes to the existing warnings on the drug (TPL September 16).