Seroxat raises suicide risk in young adults, says GSK
pharmafile | May 17, 2006 | News story | Sales and Marketing |Â Â Â
GlaxoSmithKline says new analyses of its antidepressant Seroxat show the drug raises the risk of suicidal behaviour in young adults.
The studies are the first to confirm suspicions that Seroxat can increase the risk of suicide in young adults (18-29 years of age), who were found to be at a higher background risk than older adults.
The new evidence has prompted UK regulator the MHRA to remind doctors to monitor these patients with particular care, but it said the drug's overall benefit/risk profile was still favourable.
The results seem to confirm long-standing claims from some patients, who have complained of a number of serious side-effects when taking Seroxat. The drug has seen its use decline in the UK because of these concerns but, nevertheless, it remains one of the most commonly prescribed anti-depressants.
The new analyses of the risk of suicidal behaviour in adults were conducted as part of an on-going review by US regulator the FDA, and follow a ban of SSRI use in children and adolescents in 2004 after studies established a raised risk of suicide within that age group.
UK regulator the MHRA has now re-emphasised the need to monitor all patients treated with SSRIs for the worsening of symptoms or mood changes, but has not altered the prescribing advice issued for SSRIs in 2004. This guidance was given following a comprehensive review of data by an expert MHRA committee, which looked in to the safety of SSRIs and similar drugs.
In a letter sent to every GP in the country, Professor Gordon Duff, chairman of the regulator's expert committee the CHM, said: "Following our further investigations and discussions with other European regulatory agencies, the Seroxat product information for prescribers and patients will be updated as needed."
He stressed that careful and frequent patient monitoring by healthcare professionals (and others carers where appropriate) is important in the early stages of treatment with Seroxat, especially if a patient experiences any worsening of symptoms or if new symptoms arise after starting treatment.
The MHRA had already warned doctors to monitor young adults aged 18-29 more closely, and the new evidence has shown this precautionary measure to be justified.
Last year, around 300,000 UK adults were prescribed Seroxat, making it one of the most frequently prescribed antidepressants. Of drugs in the SSRI class, Citalopram (Lundbeck's off-patent Cipramil) was the most prescribed in 2005, with more than five million prescriptions written in the community in England, followed by fluoxetine (Lilly's Prozac) and Wyeth's SNRI drug Efexor (venlafaxine).
