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GSK avoids punishment over antidepressant

LONDON, England (AP) — Pharmaceutical giant GlaxoSmithKline has escaped prosecution for allegedly withholding data on clinical trials of its antidepressant drug Seroxat.

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

However, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) said Thursday that there was no reasonable prospect of a conviction in the case when it announced the conclusion of a four-year review.

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.

Glaxo handed over data from clinical trials in 2003 which indicated that patients under 18 had a higher risk of suicidal behavior if they were treated with Seroxat compared to those receiving a placebo. The research also indicated that Seroxat was ineffective in treating depressive illness in those aged under 18.

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 Dr. Alastair Benbow, medical director for GlaxoSmithKline’s European operations.

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

It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company, McCulloch said.

MHRA chief executive Kent Woods said he was still concerned that Glaxo could and should have reported this information earlier than they did.

This investigation has revealed important weaknesses in the drug safety legislation in force at the time, Woods said.

Subsequent legislation has partially addressed the problem, but 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.

Glaxo pledged its cooperation.

GSK is committed to working with the Government, appropriate regulatory authorities and other pharmaceutical companies to take whatever action is necessary to improve legislation and policy in this area, Benbow said.

GlaxoSmithKline shares were down 1.2 percent on the London Stock Exchange at midday at 1052 pence ($20.88).
GSK avoids punishment over antidepressant – found here.

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March 6, 2008 - Posted by | Uncategorized

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