Category: Warning/Recalls Region: Europe · United Kingdom Company: Glaxosmithkline Uk Ltd

GSK issues Seroxat warning letter

GSK issues Seroxat warning letter
Antidepressant linked to increased risk of suicidal behaviour in young adults GlaxoSmithKline (GSK) has sent a letter to doctors warning them that there could be an elevated risk of suicidal behaviour in adults under 30 taking its antidepressant, Seroxat (sold as Paxil in the US). Having reanalysed data from clinical trials involving almost 15,000 people, the firm said there was a higher frequency of suicidal behaviour in young adults treated with the drug for depression than in those taking a placebo. The new analysis comes after the US Food and Drug Administration asked all manufacturers of anti-depression treatments to evaluate whether their products increased the risk of suicidal thoughts among adults. The FDA said its review of antidepressants is not yet complete and patients taking such drugs should be carefully monitored for worsening of depression and suicidal thinking. It also said it is essential that patients on Seroxat don't stop taking it suddenly. In a statement, GSK said that

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