The U.S. Food and Drug Administration and GlaxoSmithKline PLC (GSK) said on May 12th that an analysis of clinical trials involving the antidepressant Paxil showed a small increase in suicidal behavior, particularly among young adults.

The company said it conducted an analysis of studies that involved almost 17,000 adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders

"Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo," the FDA said in a statement posted to its Web site Friday.

"In the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo," the FDA added. "This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution."

The FDA said all of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-to-30.

GlaxoSmithKline updated the label of Paxil -- which already carries a black-box warning about a possible increase in suicidal thoughts and behaviors in children and adolescents -- to reflect the new data.

Source: Medical Week staff, week of May 10, 2006