Weight Loss News

Rimonabant will remain on European Shelves but along with stronger Warning

24 July 2007

Going by the decision of the European Medicines Agency (EMEA), the blockbuster diet drug Acomplia will be available in the European market but will encompass a stronger safety warning in relation to the psychiatric side-effects.

On July 19th, the EMEA finally reached to this decision that acomplia or rimonabant will remain on sale in the Europe after overhauling the safety data that provoked the U.S. FDA's advisory panel to collectively rebuff the drug's approval for sale in the United States under the new name "Zimulti".

The EMEA's Committee for Medicinal Products for Human Use (CHMP) averred that it asked Sanofi-Aventis to propose all available data on the drug's psychiatric side effects subsequent to the FDA's advisory panel summit in June 2007.

While assessing data on the drug's safety during its just concluded July meeting, the CHMP earlier stated that "the benefits of rimonabant persist to prevail upon its risks, excluding the patients having constant major depression or who are consuming antidepressants."

The breakthrough weight-loss preparation is permitted to be sold in Europe as an add-on to exercise and diet for the management of weight in obese and overweight adult patients.

The EMEA further articulated that though the doctors were warned when rimonabant was approved a year back that they should not recommend the preparation in patients with unrestrained serious psychiatric conditions including major depression, the warning will now be improved.

"From now, it is mandatory for the drug maker to include more strong warning concerning the unsuitability of Acomplia in patients with constant major depression or who are already been treated with antidepressants because of the associated psychiatric side effects". In addition, the CHMP also advised to include a warning that the use of Acomplia should be blocked once a patient builds up depression.