Will diet drug Acomplia (rimonabant), taken this past year by more than 100,000 Europeans seeking to lose weight, be pulled from the European market out of concern over depressive and suicidal side-effects?

That decision will be made known July 19th following this week's safety review by the European Medicines Agency (EMEA) of data which led a U.S. Food and Drug Administration advisory panel to recommend that rimonabant not be sold in the United States.

EMEA regulators said that since the unanimous FDA advisory panel decision in mid-June recommending against sale of Acomplia, they have been "reviewing the available data on psychiatric events" including suicidal ideation and depression-related events.

The EMEA's post-marketing data showed that 208 psychiatric adverse events were reported with Acomplia during the year it has been on the market, including 27 cases of suicidal ideation (thoughts of suicide).

That compared with 14 cases of suicidal ideation with diet drug Xenical since its 1998 launch. The reports of Acomplia safety events, however, were the result of patient monitoring, whereas those for Xenical were unprompted.

While Sanofi-Aventis pulled its application to sell rimonabant -- which would have been marketed as Zimulti in the United States -- until more data on long-term side-effects is available from clinical trials, the French pharmaceutical giant is hoping Acomplia will be allowed to remain on the market in Europe.

The EMEA's Committee for Medicinal Products for Human Use convened in London July 16th and indicated it would announced its decision by meeting's end July 19th.

"They will recommend whatever they think is appropriate. It ranges from nothing to new warnings or other restrictions or contraindications to suspension or withdrawal," according to an EMEA spokesperson.

Most analysts expect that European officials will allow Acomplia to remain on the market, but possibly with a strengthening of warnings that already limit the use of the diet drug to patients with no history of major depression.

Meanwhile, a U.S. consumer group urged the EMEA to withdraw Acomplia and an arthritis drug, Merck's Arcoxia, from sale.

"These drugs are too dangerous,"said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "Their benefits are greatly outweighed by the risks."