Weight Loss Information

Taking diet drug Acomplia (rimonabant) approximately doubles your risk of depression, and the risk may be even higher if you have a past history of depression, according to the European Medicines Agency (EMEA).

"This doubling of the risk of depression occurs in all types of patients," the EMEA's Committee for Medicinal Products for Human Use (CHMP) said in the most definitive statement to date quantifying the link between Acomplia and depressive side effects.

"This increased risk is of concern, since Acomplia is now being used in patients with a history of psychiatric events," said the CHMP. "In a small minority of cases, this could lead to suicidal ideation or even suicide attempts."

The CHMP reached the conclusions about the link between Acomplia and depression after analyzing a year's worth of data it requested from Sanofi on "the psychiatric safety of Acomplia, focusing on cases of depression in patients taking the medicine."

Sanofi provided data on the more than 100,000 patients who have taken Acomplia in Europe since it was approved for sale in the European Union.

In assessing the data, 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."

But it expressed concern that "too many patients are taking Acomplia at the same time as antidepressants, even though Acomplia is not recommended for use in patients also taking antidepressants."

"Acomplia must no longer be used in these patients," the CHMP said in approving stiffer warnings to doctors not to prescribe Acomplia for depressed patients.

Meantime, regulators in the U.K. -- where more patients have taken Acomplia in the past year than any other country -- said evidence suggests one person in 10 experiences psychiatric side effects and about one person in 100 experiences suicidal thoughts while on the diet drug.

Sanofi-Aventis said on April 3rd it still has high hopes for diet drug rimonabant (Acomplia / Zimulti), even though it was rejected by a U.S. FDA advisory panel last year and recent clinical trial news has been less than wildly encouraging.

Marc Cluzel, Sanofi's head of research, said in a round of interviews in London that he continues to believe Acomplia can be a winner.

Acomplia, which was to have been marketed in the United States as Zimulti, was withdrawn from FDA consideration last June after an expert panel unanimously recommended against approval out of concern over depressive and suicidal side-effects.

Data from a new clinical trial of possible use of Acomplia in slowing progression of coronary artery disease was reported this week along with news that 43.4 percent of patients who got rimonabant in this trial suffered psychiatric side effects such as anxiety and depression.

While the results of the heart trial were ambiguous at best, Cluzel put a positive face on it -- and reiterated that Sanofi intends to resubmit rimonabant to the FDA and regulators worldwide in 2009 for approval as a treatment for type 2 diabetes.

He noted that the Acomplia development program -- involving clinical trials for a variety of conditions in addition to obesity -- is only one-third completed.

"It's very difficult before 2011 to know exactly what will be the full benefits of the product," Cluzel told the news agency Reuters.

Another Sanofi executive, Belen Garijo, also expressed confidence that sales of Acomplia -- which have been disappointing to date -- will grow in Europe and other countries where it is on the market. http://www.acomplia.p5.org.uk