Suicide risk higher in young adults on Paxil

May 22, 2006

The FDA and GlaxoSmithKline are notifying healthcare professionalsof changes in the Warnings section of the prescribing informationfor both Paxil (paroxetine) and Paxil CR, after a company-performedmeta-analysis found an increased risk of suicidal behavior in youngadults (aged 18-24) taking the drug (2.19% versus 0.92% onplacebo). The clinical trials analyzed included almost 9,000patients treated with paroxetine and about 6,000 on placebo.

Suicide risk higher in young adults on Paxil

The FDA and GlaxoSmithKline are notifying healthcare professionals of changes in the Warnings section of the prescribing information for both Paxil (paroxetine) and Paxil CR, after a company-performed meta-analysis found an increased risk of suicidal behavior in young adults (aged 18-24) taking the drug (2.19% versus 0.92% on placebo). The clinical trials analyzed included almost 9,000 patients treated with paroxetine and about 6,000 on placebo. Although this finding was not significant, when GSK examined adults (all ages) with Major Depressive Disorder (MDD), there was a significant difference in frequency of suicidal behavior in patients treated with paroxetine compared with placebo (0.32% versus 0.05%). GSK said it is difficult to conclude a causal relationship between the drug and suicidality due to the small incidence and the fact that suicide can be a symptom of the psychiatric illness itself, but that the MDD data suggest the higher frequency may extend beyond the age of 24. The company reminds clinicians of the importance of careful monitoring of all patients, especially young adults, receiving treatment with paroxetine regardless of the condition being treated.

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