NY sues GSK over Paxil

New York's Attorney General, Eliot Spitzer, has filed a lawsuit against GlaxoSmithKline, accusing it of hiding negative information about the effects of its anti- depression drug Paxil when prescribed for children.

The consumer-fraud suit was filed today in New York State Supreme Court in Manhattan, Spitzer's office said in a statement on the state's Web site.

The lawsuit alleges that: 'starting in 1998, GSK engaged in a concerted effort to withhold negative information concerning Paxil and misrepresented data concerning Paxil's safety and efficacy when prescribed for depression in children and adolescents,' Spitzer's statement said.

A spokesman for Glaxo, Chris Hunter-Ward, declined to comment on the suit today.

While Paxil has been approved by the FDA for adults only, physicians have discretion to prescribe the drug to treat depression in children, a so-called off-label use, Spitzer said.

Glaxo conducted at least five studies on the use of Paxil for children and adolescents, according to the statement. Only one study, showing mixed results, was published and disseminated, Spitzer said.

The suit alleges that Glaxo: 'suppressed the negative results of the other studies, which failed to demonstrate that Paxil is effective and which suggested a possible increased risk of suicidal thinking and acts,' the attorney general's statement said.

The company also failed to disclose the negative information to physicians, Spitzer said.

Source: Bloomberg.com