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Makers of Paxil Sued for Fraud

New York Attorney Genral Eliot Spitzer filed a lawsuit in New York State Supreme Court Wednesday charging GlaxoSmithKline PLC with committing fraud by withholding the results of four research studies that showed Paxil was not effective in treating children and caused possible increases in suicidal thoughts and acts.

The lawsuit comes closely after the U.S. Food and Drug Administration in March issued a warning that doctors should closely monitor all patients taking antidepressants for signs of suicidal behavior and asked the makers of the drugs to add or strengthen suicide warnings on their labels.

In the New York lawsuit, Spitzer cited an internal GlaxoSmithKline memo that said the company intended to "manage the dissemination of data in order to minimize any potential negative commercial impact", according to press reports.

Glaxo spokeswoman Mary Anne Rhyne told reporters, the company "acted responsibly in conducting the studies in pediatric patients and disseminating results. All of our studies have been made available to the (U.S. Food and Drug Administration) and regulators worldwide."

Thursday June 3, 2004 | comments (0)

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