GlaxoSmithKline Sued Over Antidepressant

By Agence France-Presse New York State Attorney General Eliot Spitzer filed a lawsuit June 2 against GlaxoSmithKline (GSK) PLC, accusing the British pharmaceutical giant of concealing information about an antidepressant drug. The lawsuit alleged that, starting in 1998, GSK engaged in a concerted effort to withhold negative information concerning the drug Paxil and misrepresented data concerning its safety and efficacy when prescribed for depression in children and adolescents. Spitzer's office specifically pointed to at least five studies GSK ordered on the use of Paxil in pre-adults. Only one study was released, while the negative results of the others -- including a possible increased risk of suicidal thinking and acts--were suppressed, said the suit, filed in New York State Supreme Court in Manhattan. GSK was also alleged to have failed to disclose this information in "Medical Information Letters" that it sent to physicians. Responding to the suit, GSK said in a statement that the company had "acted responsibly" in conducting clinical studies in pediatric patients and disseminating data from those studies. All the studies "have been made available to the [U.S. Food and Drug Administration] and regulatory agencies worldwide," the statement said. The lawsuit seeks disgorgement of all profits obtained by GSK as a result of the conduct alleged in the suit. More than 2 million prescriptions for Paxil were written for children and adolescents in the United States in 2002. Nearly 900,000 were for youngsters whose primary diagnosis was a mood disorder, the most common of which is depression. Prescriptions for Paxil to treat mood disorders in children and adolescents translated into U.S. sales for GSK of approximately $55 million in 2002 alone, Spitzer said. Copyright Agence France-Presse, 2004

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