Paxil Label Updated to Include High Rate of Suicidality in Young Adults
May 12, 2006
WASHINGTON, D.C. - GlaxoSmithKline and the FDA have updated Paxil's warning label to caution that a higher frequency of suicidal behavior in young adults treated with the antidepressant was identified in a recent study.
The FDA said the results of a recent meta-analysis conducted on suicidal behavior and ideation in placebo-controlled clinical trials in adult patients with psychiatric disorders, including Major Depressive Disorder (MDD), showed a higher frequency of suicidal behavior in young adults treated with Paxil (paroxetine) compared with placebo.
"Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in …
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