GlaxoSmithKline ( GSK ) has advised HealthCare Professionals of important changes to the Clinical Worsening and Suicide Risk subsection of the Warnings section in the labels for Paxil ( Paroxetine ) and Paxil CR ( Paroxetine Controlled-Release Tablets ).

GSK has recently conducted a new meta-analysis of suicidal behavior and ideation in placebo-controlled clinical trials of Paroxetine in adult patients with psychiatric disorders including major depressive disorder ( MDD ),other depression and non-depression disorders ( e.g., dysthymia, panic disorder, generalized anxiety disorder, obsessive compulsive disorder ).
These trials included 8958 patients treated with Paroxetine and 5953 with placebo.

Results of this analysis showed a higher frequency of suicidal behavior in young adults ( prospectively defined as age 18-24 ) treated with Paroxetine compared with placebo ( 2.19% versus 0.92% ).
In the older age groups ( 25-64 years and 65 years and over ), no such increase was observed.
This finding in young adults was not statisticially significant; however, the difference was observed in Paroxetine-treated patients with both depressive and non-depressive conditions.

Further, in the analysis of adults with major depressive disorder ( all ages ),the frequency of suicidal behavior was higher in patients treated with Paroxetine compared with placebo ( 0.32% versus 0.05% ).
This difference was statistically significant; however as the absolute number and incidence of events are small, these data should be interpreted with caution.
All of the reported events of suicidal behavior in the adult patients with major depressive disorder were non-fatal suicide attempts, and the majority of these attempts ( 8 of 11 ) were in younger adults aged 18-30.

The possible increase in risk of suicidal behavior in the MDD studies was observed despite substantial evidence for efficacy in the Paroxetine-treated patients ( compared with placebo ) as determined by standardized disease-specific instruments ( e.g., Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale for depression ).
Most patients had an identified social stressor at the time of the event.

It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during Paroxetine therapy regardless of the condition being treated.

Source: FDA, 2006


XagenaMedicine2006