UK DoH to sue GSK over Seroxat data?

13 June 2004

Speculation has been growing that the UK government could be close to bringing legal action against GlaxoSmithKline, similar to the suit brought this month by New York State Attorney General Eliot Spitzer, which says the firm withheld and misrepresented negative information regarding the prescribing of its antidepressant Seroxat/Paxil (paroxetine Hl) to children and adolescents (Marketletter June 7).

The report of an investigation into the matter by the UK Medicines and Healthcare products Regulatory Agency is to be published shortly, the Department of Health has announced.

Responding to the US legal action, GSK said it acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies. All pediatric studies had been made available to the US Food and Drug Administration and regulatory agencies worldwide, said the firm, adding: "we have publicly communicated data from all pediatric studies."

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