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Home Industry News GSK acknowledges MHRA study into Seroxat

GSK acknowledges MHRA study into Seroxat

7th March 2008

GlaxoSmithKline (GSK) has acknowledged the conclusions made by the Medicines and Healthcare products Regulatory Agency (MHRA) over the disclosure of paediatric trial data for the anti-depressant Seroxat (paroxetine).

Dr Alastair Benbow, medical director for GSK Europe, insisted that the company were committed to ensuring that all information was made available to regulators, doctors and patients.

“We firmly believe we acted properly and responsibly in first carrying out this important clinical trials programme and then informing the regulatory agencies when we identified a potential increased risk of suicidal thinking and behaviour in patients under 18,” he confirmed.

Mr Benbow went onto acknowledge that there had to be stronger public confidence in the pharmaceutical industry’s ability to disclose data transparently.

He ended by confirming that GSK was committed to working with the relevant regulatory bodies and other pharmaceutical companies to improve legislation and policy in this area.

Following a four-year investigation into the anti-depressant and its related safety guidelines, the MHRA concluded that there were no “realistic” prospects for the prosecution of GSK but the firm should have reported certain data and guidance to the MHRA earlier than was done so.

Seroxat was originally released in 1992 and works as a selective serotonin reuptake inhibitor.

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