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PJ Online homeThe Pharmaceutical Journal
Vol 276 No 7400 p556
13 May 2006

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Paroxetine and suicidal behaviour

Oscar Burriel/Science Photo Library

Paroxetine-treated young adults

Paroxetine-treated young adults show increased suicidal behaviour

GlaxoSmithKline has declared that suicidal behaviour in young adults, especially those with major depressive disorder, may be increased during treatment with paroxetine.

An analysis of placebo-controlled trials of adults with psychiatric disorders found a higher frequency of suicidal behaviour in those aged 18–24 years treated with paroxetine than in those given placebo. The difference was not statistically significant. Another analysis found a statistically significant increase in the frequency of suicidal behaviour in patients of all ages with major depressive disorder taking paroxetine, compared with those given placebo.

“The finding of evidence of increased suicide attempts in adults with major depressive disorder treated with paroxetine compared with placebo is new, and was not found in … GSK’s prior analyses,” the company said. “Some statements in the approved prescribing information will need to be amended to reflect the results from this analysis,” it added.

Gordon Duff, chairman of the Commission on Human Medicines, has sent a letter to health professionals about the findings.

“The new analyses highlight the importance of monitoring all patients treated with selective serotonin reuptake inhibitors for worsening of their symptoms or mood changes but do not alter the prescribing advice for SSRIs issued in December 2004,” Professor Duff said in the letter. This advice was reported in The Journal at the time (PJ, 11 December 2004, p839).

GSK has published details of the analyses on its website (www.gsk.com).

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