US FDA advisory panel split on keeping Abbott's obesity drug Meridia on the market

Following concerns about the safety of obesity drugs and their risk of causing cardiovascular problems, US health care major Abbott Laboratories’ (NYSE: ABT) Meridia (sibutramine) came under scrutiny yesterday, but with no clear outcome as regulatory advisors were split on whether the drug should be pulled from the market.

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee reviewed the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication 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.

"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, vice president, Global Pharmaceutical Development, at Abbott. "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine. Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."