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Glaxo Faces Lawsuits from U.S. Parents Over Paxil

Mon Sep 6, 4:42 AM ET

LONDON (Reuters) - GlaxoSmithKline Plc is facing a number of lawsuits from U.S. parents of children and adolescents given its antidepressant Paxil, following claims the company suppressed data showing the drug increased suicidal tendencies in young people.

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A company spokesman confirmed on Monday that a number of suits had been received, adding the company intended to defend itself. GSK has denied covering up clinical trials results.

At least one case is a class-action suit.

The action by families comes in the wake of a legal clash with New York Attorney General Eliot Spitzer, who had accused GSK of withholding negative information about Paxil.

In the event, Europe's biggest drug maker settled the Spitzer case last month for a surprisingly small $2.5 million.

Paxil, which is sold as Seroxat in Europe, used to be GSK's biggest selling product. But the medicine has declined in importance following the arrival of cheap generic versions of the drug in the United States.

The pharmaceutical industry has been criticized for keeping quiet about negative results from clinical trials, since bad publicity would make product marketing more difficult.

In the case of Paxil, the drug was never approved for pediatric use and was therefore only given to children on an off-label basis at the discretion of doctors. But various trials were conducted on its use in children and adolescents.

GSK has defended the way in which it handled findings from these studies.

"We've made data available in various forms, as is normal practice, via journals, presentations at scientific meetings and in letters to healthcare professionals," the company spokesman said.

"We also submitted all the trial data to regulatory authorities."

GSK is also facing several lawsuits over adverse side effects and withdrawal problems with Paxil involving adults.

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