European agency spreads Aropax suicide warning

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 in Europe.

Seroxat (known as Aropax in New Zealand) is among the biggest selling drugs in the world and is taken by between 600,000 and 800,000 people in Britain, of whom "a significant proportion" are aged under 30, says the manufacturer, GlaxoSmithKline.

The drug has been at the centre of a major Government investigation of all selective serotonin re-uptake inhibitors (SSRIs) in Britain over claims they increase suicide and cause withdrawal problems.

The British Medicines and Healthcare Products Regulatory Agency (MHRA) launched the investigation last year but its findings have been overtaken by the European Agency for the Evaluation of Medicinal Products (EMEA), which licenses drugs for use in the European Union.

An agency committee has recommended that Seroxat, already banned for those under 18 in Britain because of an increased suicide risk, should be prescribed with extra caution to people aged 18 to 29.

"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," it says.

The recommendation by the EMEA's Committee for Proprietary Medicinal Products was made in April and is awaiting ratification by the EU commission, expected in the northern autumn, when it will become law in all member states.

The committee added warnings about the risk of withdrawal symptoms from Seroxat and echoed the ban on prescribing to under-18s already imposed in Britain.

But it has cleared the drug for continued use in Europe, because the benefit-risk ratio "remains positive."

The MHRA endorsed the findings of the European agency as "sensible advice". But it has issued no warning about the dangers of the drug in people aged 18 to 29.

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: "It's appalling. Unless you tell GPs to monitor people under 30 they won't do it."

The European agency conducted its own review in response to a request from the MHRA, so prescribing of Seroxat could be harmonised throughout Europe.

Fears that Seroxat was unsafe were aired in two BBC television Panorama programmes in 2002 and 2003 which provoked 67,000 calls and 1400 emails, the biggest response in the programme's history, and led directly to the Government review.

The MHRA banned Seroxat in under-18s in Britain in June last year, two weeks after GlaxoSmithKline supplied it with evidence from trials of Seroxat in children carried out years earlier.

The ban was extended to other antidepressants in the same class, except Prozac.

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

After banning the drug in children, the MHRA said it would "urgently examine" the implications of the studies for adults. That investigation has been widened to include all other selective serotonin re-uptake inhibitors.

New Zealand keeps a watchful eye

New Zealand authorities are collecting publications on the safety of selective serotonin re-uptake inhibitors and may seek data from the European agency after the latest warning on Seroxat (known here as Aropax).

In March, the senior medical adviser for the medicines safety authority Medsafe, Dr Stewart Jessamine, said the SSRI antidepressants could continue to be used, with the support of specialist advice. The decision would be reviewed when more detailed study results come out.

Last week, Dr Jessamine said extensive warnings were already in place for use of Aropax, similar to those being proposed in Europe.

Last year, GlaxoSmithKline wrote to NZ doctors advising them to consider gradually taking patients under 18 off Aropax.

Nearly 1800 6- to 18-year-old New Zealanders took SSRIs last year, including about 500 on Aropax.

- INDEPENDENT