Patients taking antidepressant drugs may be at increased risk of suicide in the early stages of recovery, according to a revised drug label agreed on by manufacturers and the UK Medicines Control Agency (MCA), GlaxoSmithKline said on Monday.
The company, which markets the selective serotonin reuptake inhibitor (SSRI) Seroxat (paroxetine), known as Paxil in the United States, said in a statement that SSRI manufacturers had been working with the MCA to agree to changes to the summary of product characteristics and patient leaflet.
It denied the update was a reaction to the $6.4 million awarded last month by a US jury that decided Paxil was largely to blame for the behaviour of Donald Schell, who after taking the pill, shot dead his daughter, 9-month-old granddaughter and wife, and then killed himself. The company reaffirmed it would appeal the verdict.
GSK said that the revised label, issued 2 weeks ago for Seroxat and other SSRIs, refers to the risk of suicide and recommends that patients should be closely monitored during the first few weeks or more of treatment as they may not get better immediately. Patients generally need to take an SSRI for several weeks before the drug begins to take effect.
Claims that SSRIs can trigger violent or suicidal behavior have sparked scientific controversy and prompted legal claims for compensation. Last month David Healey, director of the department of psychosocial medicine in Bangor, North Wales, said his studies showed that SSRIs can cause even healthy volunteers to suffer dangerous reactions.
“Controlled studies of the relationship between suicide and Seroxat have not provided any evidence that Seroxat causes suicide. On the contrary, these studies demonstrate that Seroxat reduces newly emergent suicidal thoughts and suicide attempts.”
The revised label also refers to possible withdrawal symptoms on stopping SSRI treatment and advises gradual discontinuation by dose tapering. It says the available evidence does not suggest such symptoms are due to dependence. The reactions themselves were usually mild and self-limiting.
An MCA spokesperson told Reuters Health that the Committee on Safety of Medicines (CSM) reviewed available data in June 2000 and concluded that the evidence from studies did not suggest there was a causal relationship between SSRIs and suicidal behaviour. However, because of continued anecdotal reports it felt the issue should be closely monitored.
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