Thursday, March 06, 2008

GSK - Seroxat/Paxil: MHRA toughen up the law

Britain is to strengthen the law on disclosing drug trial results following a four-year inquiry into GlaxoSmithKline's delay in reporting data linking its antidepressant Seroxat to suicide risk in teenagers.

"We will take immediate steps to ensure the law is strengthened further, so that there can be no doubt as to companies' obligations to report safety issues," Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said in a statement on Thursday.

The watchdog advised doctors in 2003 not to give Seroxat to patients under the age of 18, after Glaxo handed over data showing it could increase their risk of suicidal behaviour.

An investigation with a view to potential criminal prosecution was launched due to concerns that Europe's biggest drugmaker had held the information for some time before this and failed to disclose it.

But GSK have avoided prosecution.

More from Ben Hirschler at Reuters

MHRA documents.

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