Seroxat also linked to suicide in adults, admits pharmaceutical company

Mental Health Nursing,  Jul 2006  

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GlaxoSmithKline (GSK), the manufacturer of the controversial antidepressant drug Seroxat, has admitted that the medication can result in adults becoming suicidal.

In 2003 the Department of Health ruled that Seroxat should not be prescribed to children after the Committee on Safety of Medicines, (CSM) and its Expert Working Group on SSRIs determined that there was an increase in the rate of self-harm and potentially suicidal behaviour among under-18s when Seroxat was used for depressive illness.

Now the pharmaceutical company has admitted that the drug - which was prescribed to 300,000 people last year - may also pose similar risks to adults.

GSK has sent a letter to all doctors in the UK warning of the potential risks to adults, while a statement on their website admits: 'GSK has conducted three analyses of adult suicidality: (1) the European Article 31 Referral (a European regulatory process involving a series of requests for analyses of clinical trial data), conducted during 2003 and 2004; (2) a 2004 report of the UK s General Practice Research Database (GPRD), an epidemiological database; and (3) an analysis recently completed in 2006 that is similar to FDA's ongoing review of antidepressants and suicidality. The results of the 2006 analysis indicate that young adults, particularly those with Major Depressive Disorder, may be at increased risk for suicidal behaviour with paroxetine [Seroxat]'.

After reanalysing data from clinical trials, as requested by the US drug regulator, the Food and Drug Administration (FDA), GSK determined that significantly more adults who were given Seroxat exhibited suicidal behaviour than those administered a placebo.

The Medicines and Healthcare Products Regulatory Authority (MHRA) has ordered a review into the drug Dianette - used both as a treatment for severe acne and as a contraceptive - after a report from the chanty APRIL (Adverse Psychiatric Reactions Information Link) suggested it may increase the risk of depression in young women.

Copyright Community Psychiatric Nurses Association Jul 2006
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