Diet drug Acomplia (rimonabant) will remain on the market in Europe but will carry a stronger safety warning about psychiatric side-effects, European regulators decided on July 19th.

The European Medicines Agency (EMEA) made the decision to let the diet drug remain on the market after reviewing safety data that led a U.S. FDA advisory panel last month to unanimously recommend against allowing rimonabant (also known as Zimulti) to be prescribed in the United States.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) said it asked Sanofi-Aventis following the FDA advisory panel meeting in June 2007 to "submit all available information on the psychiatric side effects of Acomplia."

In assessing the data at its just concluded July meeting, the CHMP said it concluded "that the benefits of Acomplia continue to outweigh its risks, except in patients with ongoing major depression or taking antidepressants."

Acomplia is approved in Europe as an adjunct to diet and exercise for the treatment of obese or overweight adult patients.

The EMEA said that while doctors were warned when rimonabant was approved a year ago that they " should not prescribe Acomplia in patients with uncontrolled serious psychiatric conditions such as major depression," the warning will now be upgraded.

The CHMP said it is now recommending " contraindicating Acomplia (rimonabant) from Sanofi-aventis, in patients with ongoing major depression or who are being treated with antidepressants, because of the risk of psychiatric side effects.

Additionally, the CHMP "recommended adding a warning that treatment with Acomplia should be stopped if a patient develops depression, as well as the
inclusion of additional information on the psychiatric safety of Acomplia.

"Patients and their carers should be aware of the risk of depression in patients taking Acomplia," the CHMP added.

Acomplia is currently marketed in 13 European Union nations as well as in Argentina, Mexico and a handful of other countries.