Brushed Under The Carpet III

...and are we led to beleive that the following sham of an investigation is still ongoing?

Seroxat controversy deepens with Europe-wide warning on suicide

Source: netdoctor.co.uk 2004


A new warning that the controversial antidepressant Seroxat may increase the risk of suicide in young adults up to the age of 30 is to be issued throughout Europe.

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 the 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 suicide and cause withdrawal problems. The UK Medicines and Healthcare products Regulatory Agency (MHRA) 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.

A committee of the agency has recommended that Seroxat, which 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. The committee also warned about withdrawal symptoms from Seroxat and echoed the prescribing ban for under-18s.

But it has cleared the drug for continued use in Europe on the grounds that the benefit-risk ratio "remains positive". The MHRA 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. TheEMEA conducted its safety review in response to a request from the MHRA, in order that prescribing of Seroxat could be harmonised throughout Europe.

Richard Brook, chief executive of Mind, the mental health charity, said: "Why on earth has the MHRA not made more widely known the danger to young adults? It seems extremely bizarre." Janice Simmons of the Seroxat Users Group said: "Its appalling. Unless you tell GPs to monitor people under 30 they won't do it."

Fears that Seroxat was unsafe were aired in two BBCPanorama programmes in 2002 and 2003. They provoked 67,000 calls and 1,400 e-mails, the biggest response in the programme's history, and led to the review by the MHRA. Two weeks after GlaxoSmithKline supplied it with evidence from trials of Seroxat in children carried out years earlier, the drug was banned. The ban in under-18s was extended to all other SSRIs, except Prozac.

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

The MHRA is now also examining the implications of studies with all SSRIs for adults. But the outcome of a key part of that review, expected in October, has been upstaged by the EMEA's decision. Mr Brook, who resigned from the MHRA's SSRIs working group earlier this year, said: "It is extremely difficult to see how the MHRA can come to a different decision that contradicts EU law. Government announcements on this issue have perhaps been misleading."

The Department of Health failed to respond to requests for a comment.