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NYS Attorney General Files Lawsuit Against GlaxoSmithKline for Paxil Risk
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GlaxoSmithKline sued in US over anti-depressant
NEW YORK (AFP), June 2, 2004 - New York State Attorney General Eliot Spitzer filed a lawsuit against GlaxoSmithKline (GSK), accusing the British drugs giant of concealing information about an anti-depressant 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. "By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety," Spitzer said. An internal GSK document from 1999, cited in the lawsuit, shows that GSK intended to "manage the dissemination of (the) data in order to minimize any potential negative commercial impact." The lawsuit seeks disgorgement of all profits obtained by GSK as a result of the conduct alleged in the suit. More than two 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 US sales for GSK of approximately 55 million dollars in 2002 alone, Spitzer said. © 2004 AFP |