GSK defends anti-depressants over suicide fears

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The Independent Online

GlaxoSmithKline, the biggest drugs maker in the UK, was forced yesterday to defend its best-selling antidepressant against new claims that it causes serious side effects in adults.

GlaxoSmithKline, the biggest drugs maker in the UK, was forced yesterday to defend its best-selling antidepressant against new claims that it causes serious side effects in adults.

Concern is growing in the City that sales forecasts for Seroxat could prove too ambitious if there is a backlash against the drug.

Seroxat, and several other drugs in the same class, were banned last year for use by under-18s and the Europe-wide regulator, the EMEA, has since warned that the drug also induces suicidal thoughts in adults aged up to 30.

A BBC Panorama investigation on Sunday presented new claims from medical experts that the drug can increase the risk of patients taking their own lives - claims that GSK denies.

GSK faces claims for damages from patients and their families in the UK and the US, where it is sold under the name Paxil.

The company could also face criminal charges if an investigation by the MHRA, the UK medicines regulator, finds that it withheld trial results showing the increased suicide risk among adolescent patients. The company says it passed on the data as soon as its implications became clear. It settled similar claims by the New York state attorney-general, Eliot Spitzer, for the relatively small sum of $2.5m (£1.4m).

In a statement after the programme, GSK said: "Seroxat is a serious medicine designed to treat serious psychiatric diseases that cause many thousands of premature and often preventable deaths every year. Seroxat also has a well understood safety profile."

GSK has been forced to fight the rearguard action to defend what, despite the loss of sales to copycat products after patents expired last year, is still one of its best-selling drugs.

Peter McDougall, the founder of the independent pharmaceuticals research group DrugAnalyst, said that the City's forecasts of £1bn of sales in 2006 could prove optimistic. He said: "If only half the concerns expressed by the BBC journalists were ever proven true, we worry that Seroxat/Paxil would not hit these ambitious forecasts."

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