Suicidality:Foucus of FDA Panel Meeting

The FDA advisory panel meeting which was held on June 13, 2007 focused the incident of suicide attempted during the clinical trial of the diet drug acomplia.

The relationship between rimonabant, depression and suicide has become a big concern for them.

Dr. Kelly Posner of the New York State Psychiatric Institute said , “The panel that a major challenge in assessing the number of incidents of suicidality that occurred during the trial was the wide variation that occurred from medical center to center in how patient incidents were reported.”

She added , "We found more suicidal events over all, but fewer events were labeled suicide attempts.Other events involved "suicidal ideation" which she explained as "thoughts of wanting to be dead . . . or wanting to end one's life."

The decision about approval of marketing of Zimulti in United States is expected in late July.