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The Pharmaceutical Journal Vol 267 No 7156 p39-44
July 14, 2001

News summary


SSRIs: review of suicide tendency

A WARNING that patients should be closely monitored for suicidal tendencies during the early stages of treatment with selective serotonin reuptake inhibitors (SSRIs) has been added to the summary of product characteristics for Seroxat (paroxetine). The SPCs for other SSRIs are also currently being updated.

A spokesman for the Medicines Control Agency said that the Committee on Safety of Medicines had reviewed available data and concluded that a relationship between SSRIs and suicidal behaviour could not be made. However because of continued anecdotal reports, the CSM has recommended that the issue should be monitored.

Speaking to The Journal on 10 July, a spokesman for GlaxoSmithKline, manufacturer of Seroxat, said that the company and other SSRI manufacturers had been working with the MCA on the amendments to SPCs and patient information leaflets. The company says that the possibility of a suicide attempt is inherent in depression and can persist until significant therapeutic effect is achieved. “Controlled studies of the relationship between suicide and paroxetine have not provided any evidence that the drug causes suicide. On the contrary, these studies demonstrate that paroxetine reduces newly emergent suicidal thoughts and may reduce suicide and suicide attempts,” it says.

GSK says that the update is not a reaction to the recent US court case in which the jury determined that treatment with paroxetine had influenced the behaviour of a patient who had murdered his family and committed suicide. The company is appealing against the verdict, it says.

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