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GSK denies withholding data about Seroxat

GlaxoSmithKline has denied allegations that it failed to provide important information about the adverse side effects of its drug, Seroxat, in under 18-year olds.

GlaxoSmithKline (GSK) has denied allegations that it failed to provide important information about the adverse side effects of its drug, Seroxat, in under 18-year olds.

Following the conclusion of a four-year investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), GSK says that it submitted all data from nine studies in accordance with legislative stipulations.

Seroxat, the antidepressant drug, has been found to raise the risk of suicidal thoughts or behaviour among patients under the age of 18, than those treated with a placebo.

Dr Alastair Benbow, director of GSK Europe, said: "We firmly believe we acted properly and responsibly in first carrying out this important clinical trails programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour."

Despite an extensive investigation by the MHRA, the largest of its kind in the UK, the regulator has said that government prosecutors will not be pursuing the case.

Professor Kent Woods, chief executive of the MHRA, said: "The investigation has revealed important weaknesses in the drug safety legislation in the drug safety legislation in force at the time."

"I remain concerned that GSK could and should have reported this information earlier than they did," said Woods about GSK's failure to report sooner that Seroxat causes suicidal tendencies among patients under the age of 18 suffering from depressive illnesses.

GSK said that the nine paediatric studies conducted over a period of eight years and reviewed by independent investigators showed that patients taking Seroxat did not experience a "clinically meaningful increase in the rate of suicidal thinking".

But the MHRA said that it did receive data from GSK in May 2003 that confirmed that "patients under 18 did have a higher risk if suicidal behaviour if they were treated with Seroxat".

Benbow said: "The safe use of our medicines is paramount to everyone who works for GSK and the company is committed to ensuring that all appropriate information is made available to regulators, doctors, and patients."

The MHRA expressed concerns over current legislation in place stating that it was not sufficient or comprehensive enough to place greater demands on pharma companies to disclose information about drug safety.

The results and ensuing debate surrounding the investigation into Seroxat has brought to the government's attention a greater need for more stringent legislation concerning the dissemination pertaining to drug safety and efficacy.

Health minister, Dawn Primarolo, issued a statement in the House of Commons detailing new plans to push the UK and EU for a "strengthening of law in this area".

Primarolo said that immediate steps should be taken to, "make it clear to all pharmaceutical companies that, notwithstanding the limitations that may exist in the law, they should disclose any information that have that would have a bearing on the protection of health".

Primarolo said she has asked that the law be toughened through, "changes to the EU directive and, in the meantime, amending the law as it applies in the UK."

6th March 2008

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