Glaxosmithkline Seroxat investigation concludes

A four-year investigation into an anti-depressant and its related safety guidance has concluded today.

The Medical Healthcare products Regulatory Agency (MHRA) focused on whether Glaxosmithkline (GSK) adequately informed the organisation about the safety of Seroxat for under-18s.

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

Over one million pages of evidence were examined as part of the investigation and the MHRA considered whether it was given the safety information with a satisfactory timeframe.

Although no “realistic” prospects regarding prosecution of GSK can be taken, it was said that GSK should have reported certain data and guidance to the MHRA earlier than was done so.

Government prosecutors decided that although insufficient legislation was in force at the time, the agency said Seroxat’s role in increasing the risk of suicidal behaviour in under-18s and its ineffectiveness in treating depressive illnesses for this age group should have been revealed at an earlier date.

“All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them,” said Professor Kent Woods, MHRA chief executive.

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