Safety data for diet pill Acomplia (rimonabant) will be reviewed by the European Medicines Agency (EMEA) next week after a U.S. panel of experts unanimously recommended against allowing the diet drug to be sold in the United States.

More than 100,000 people in Europe have been prescribed the diet drug since the EMEA approved it for sale last year in the European Union.

However, the FDA briefing June 13th of its Endocrinologic and Metabolic Drugs Advisory Committee included safety data submitted after European authorities approved Acomplia, and the strong concern expressed by the U.S. panel seems likely to lead to a more than routine review by European regulators.

A regular meeting of the EMEA's Committee for Medicinal Products for Human
Use (CHMP) is set for June 18-21 and a spokesperson said Acomplia will "surely" be on the agenda in view of the serious safety concerns raised by the FDA experts.

"If a big regulatory authority takes a decision or if such information comes to light then these things come on to the agenda," the spokesperson said.

While few think it likely that the EMEA will pull Acomplia from the European market, any action such as changing the labeling of the drug or the prescription guidance or issuing additional warnings could come at the end of next week.

Sanofi-Aventis said it has had no notification of any type from the EMEA.

While the drug labeling in Europe already warns of possible psychiatric
side-effects, level of concern voiced by U.S. experts after their briefing yesterday caught many by surprise.

The advisory panel unanimously concluded that available safety data that has been collected to date on rimonabant's psychiatric side-effects was not adequate, and voted 14-to-0 that based on the data, Ziimulti -- as it was to be known in the U.S. -- ought not be approved for weight loss in the United States.