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GlaxoSmithKline slammed

6th March 2008

Government ministers have pledged to tighten laws requiring drug firms to disclose data from clinical trials after claims that GlaxoSmithKline withheld information on Seroxat.

The move comes after drugs regulator the Medicines and Healthcare products Regulatory Agency (MHRA) said GSK would not face criminal proceedings over the case because there was no realistic prospect of a conviction.

But the MHRA has warned GSK that it should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s.

Seroxat was shown as not being effective for treating depression in children and adolescents and was subsequently banned for use in under 18s.

MHRA chief executive Professor Kent Woods said: “I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.

“This investigation has revealed important weaknesses in the drug safety legislation in force at the time.?

Health minister Dawn Primarolo said the government would take immediate steps try to strengthen the law in this area in the UK and Europe and that all pharmaceutical companies should disclose any information they have that would have a bearing on the protection of health.

GSK Europe medical director Dr Alastair Benbow said his company had acted “properly and responsibly? in carrying out the clinical trials programme and informing the regulatory agencies when a potential increased risk of suicidal thinking and behaviour in patients under 18 was identified.

 

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