The regulator said that although Sanofi-Aventis' clinical trials showed that patients who took the treatment daily experienced significant weight loss after two years, there were a number of psychiatric side effects from Acomplia, including depression, anxiety and insomnia.
The Associated Press said that Sanofi-Aventis' trials showed that 26% of those treated with Acomplia, known generically as rimonabant, reported psychiatric events, compared to 14% of those issued with a placebo.
In addition, the FDA drew attention to the firm's data which showed that one Acomplia patient committed suicide and eight had had suicidal thoughts, compared to two attempted suicides and five instances of suicidal thoughts reported among those patients taking a placebo.
According to Reuters, although Sanofi-Aventis said that the benefits of Acomplia outweigh the risks, the FDA is still apprehensive. The publication cited the FDA summary as saying: “We remain concerned about rimonabant's adverse event profile, specifically adverse psychiatric reactions.”
Sanofi-Aventis has recommended that the drug not be prescribed to patients with serious mental illness.
According to The Associated Press, the FDA is due to release its final decision on the licensing of the drug on July 17, 2007. Before that, outside experts will meet to decide if the treatment should be approved. The news agency said that although the FDA does not have to make the same decision, it usually does.
Acomplia is currently sold in 18 other countries. If Sanofi-Aventis does gain US approval for its treatment, it will market Acomplia under the brand Zimulti, in order to avoid misleading consumers, The Associated Press reported.