Saturday, June 14, 2008

GlaxoSmithKline faces US scrutiny over Paxil suicide link

GlaxoSmithKline (GSK), the UK's largest drug maker, is facing new scrutiny in America in the wake of a British government inquiry that found the company withheld data on the suicide risk of an antidepressant.

A US senator today asked the food and drug administration (FDA), the agency that regulates American pharmaceuticals, to follow its UK counterpart in probing whether GSK concealed clinical trial evidence.

"If the company engaged in this behaviour in the UK, then I want to make sure that the same didn't happen here in the US," Grassley said.

"The FDA should investigate this question thoroughly and be forthcoming about its findings."

The drug in question - Paxil, marketed in the UK as Seroxat - has been the subject of suicide warnings since 2003, when the British government told doctors not to prescribe it to young adults. A warning to that effect was added to its US labels in 2006.

In responding to the UK conclusion that GSK failed to inform authorities of Paxil's suicide risk, Grassley quoted the Guardian's report on imminent British legislation requiring drug companies to promptly publicise clinical trial data.


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