Healthy Skepticism Library item: 13087

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Publication type: news

Barr M.
Britain won't charge Glaxo in Paxil risk
The Philadelphia Inquirer 2008 Mar 7
http://www.philly.com/inquirer/business/20080307_Britain_wont_charge_Glaxo_in_Paxil_risk.html

Full text:

British regulators will not prosecute GlaxoSmithKline P.L.C. for allegedly withholding data about an antidepressant that may have led to an increased risk of suicide.

The Medicines and Healthcare Products Regulatory Agency, announcing the conclusion of a four-year review, said yesterday that there was no reasonable prospect of a conviction in the case that centered on the antidepressant Seroxat.

The drug is sold as Paxil in the United States, where GlaxoSmithKline has its headquarters in Philadelphia and Research Triangle Park, N.C.

Clinical trials have indicated that people under age 18 who took the medication had an increased risk of suicide.

“The legislation in force at the time was not sufficiently strong or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside its licensed indications,” the agency said.

The drug was only licensed for adults.

GlaxoSmithKline handed over data from clinical trials in 2003 that indicated patients under 18 had a higher risk of suicide when treated with Seroxat, compared with those receiving a placebo.

“We firmly believe we acted properly and responsibly in first carrying out this important clinical trials program and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behavior in patients under 18,” said Alastair Benbow, medical director for GlaxoSmithKlineEurope.

Andrew McCulloch, chief executive officer of Britain’s Mental Health Foundation, criticized the agency’s decision.