July 27, 2004

A new warning that the antidepressant Seroxat may increase the risk of suicide in young adults up to the age of 30 is to be issued throughout Europe, independent.co.uk has reported.

Seroxat is among the biggest selling drugs in the world and is taken by between 600,000 and 800,000 people in the UK, of whom "a significant proportion" are aged under 30, according to its manufacturer, GlaxoSmithKline.

The drug has been at the centre of a government investigation of all selective serotonin re-uptake inhibitors (SSRIs) in the UK over claims that they increase suicidal behaviour and cause severe withdrawal problems. The UK Medicines and Healthcare products Regulatory Agency (MHPRA) launched the investigation last year but its findings on Seroxat have been overtaken by the European Agency for the Evaluation of Medicinal Products (EMEA), which licenses drugs for use in the EU.

Independent.co.uk reported yesterday that a committee of the agency has recommended that Seroxat, which was effectively banned in under-18 year olds in the UK in June last year because of an increased suicide risk, should be prescribed with extra caution in people aged 18 to 29. It says: "There is a possibility of an increased risk of suicide-related behaviour in young adults. As a consequence young adults should be monitored closely throughout treatment."

The recommendation by the EMEA's committee for proprietary medicinal products was made in April and is awaiting ratification by the European Commission, expected in the autumn, when it will become law in member states.

But it has cleared the drug for continued use in Europe on the grounds that the benefit-risk ratio "remains positive". The MHPRA endorsed the findings of the EMEA, but it has issued no warning to British doctors about the dangers of the drug in people aged 18 to 29. The EMEA conducted its safety review in response to a request from the MHPRA, in order that prescribing of Seroxat could be harmonised throughout Europe.

Richard Brook, chief executive of Mind, the mental health charity, told independent.co.uk:: "Why on earth has the MHRA not made more widely known the danger to young adults? It seems extremely bizarre."

GlaxoSmithKline is facing fraud charges in the United States for allegedly concealing information that the drug caused suicidal behaviour in children and adolescents.

The MHPRA's report of its full investigation into SSRIs is expected by the autumn.

See
The European Agency for the Evaluation of Medicinal Products' question and answer document for professionals on Seroxat (paroxetine)

See also:
June 28, 2004: GlaxoSmithKline to publish results of clinical trials on internet in a bid to rebuild reputation after Seroxat controversy - drug firm denies decision is a result of legal action
June 14: Regulatory body to warn some SSRI antidepressants can cause adults to become suicidal
June 7, 2004: Glaxo faces Seroxat fraud lawsuit - claims that firm suppressed results of studies showing Seroxat was no more effective than a placebo and even harmful.
April 4, 2004: GPs 'forced' to overprescribe antidepressants - survey shows 80% of doctors believe they are writing too many prescriptions for SSRIs
March 28: SSRI antidepressants must carry warnings that people might become suicidal while taking them - US drug regulator states

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