US suicide hearings clear GSK

DRUGS giant GlaxoSmithKline has survived two days of hearings in the US about the effects its antidepressant, Seroxat, on stimulating suicidal tendencies in young people.

The British company emerged with its share price in New York up 71 cents yesterday to $42.86.

The hearings, ordered by the Food and Drug Administration, recommended that GSK and other drug makers be forced to put tougher warning labels on antidepressants prescribed to children and adolescents.

The antidepressants should also be delivered with an easy-to-read pamphlet explaining how to decide if the drug is appropriate for the child and how to spot the warning signs of suicide.

The panel also asked the FDA to consider making parents sign a form agreeing that they understand the risks from the drugs.

Confirmation by the hearings that there was only a small risk of teens developing suicidal tendencies also lifted the share prices of the other pharmaceuticals companies involved, including Bristol-Myers Squibb, Pfizer, Wyeth, Forest Laboratories and Eli Lilly.

The FDA advisory panel said evidence from two dozen clinical trials of nine of the newest antidepressants showed that children treated with the drugs were more likely to report suicidal thoughts or actions. No suicides occurred during the trials.

'The purpose is to put physicians on notice that this group of medicines can cause problems,' said panel member Dr James McGough, a child and adolescent psychiatrist from Los Angeles.

The panel also agreed that while the antidepressants could trigger suicidal tendencies, the drugs were an effective tool in treating depression in children and adolescents.

Only Lilly's Prozac has been approved by the FDA for use by children. Legally, however, US doctors are free to prescribe to children other antidepressants that are generally available to adults.

The lack of damning new evidence at the hearings provides a little respite for GSK.

The company recently agreed to pay a $2.5m (£1.4m) fine for not releasing research evidence that questioned the effectiveness of Seroxat (known as Paxil in the US) and not publishing relevant data that showed that the drug might not work as prescribed.

Despite assurances it would now release the data, the settlement with New York's aggressive Attorney General, Eliot Spitzer, has led several parents to file lawsuits.

Spitzer also took exception to GSK's spin on the fine and said his office would continue to monitor how the company operates in America.