GSK hit by UK Seroxat probe

Related tags Healthcare products regulatory Selective serotonin reuptake inhibitor

The UK's Medicines and Healthcare products Regulatory Agency has
asked for prescribing restrictions on GlaxoSmithKline's
widely-prescribed antidepressant Seroxat.

The UK's Medicines and Healthcare products Regulatory Agency has asked for prescribing restrictions on GlaxoSmithKline's widely-prescribed antidepressant Seroxat (paroxetine), which contributes more than £2 billion (€2.8bn) in annual turnover to the group.

The MHRA is focusing on potential side-effect problems among under-18s, although it should be noted that the drug is not approved for use in this age group. However, it is still possible for doctors to prescribe the drug to children on an 'off-label' basis.

There have been persistent allegations that GSK has suppressed a series of negative studies surrounding Seroxat - particularly with regard to a link with suicidal behaviour and potential withdrawal reactions - culminating in a high-profile exposé piece by the BBC's Panorama team, aired on UK television last month.

A panel set up by the MHRA last December to investigate the safety profile of Seroxat and other selective serotonin reuptake inhibitor antidepressants was abandoned in March after two of the group members were linked to drug companies. However, two weeks ago a second expert group was set up to review the drug.

In 2001, a jury in the USA awarded $6.4 million (€5.5m) to the family of a man who murdered his wife, daughter and granddaughter and then committed suicide in what the family claimed was a reaction to the drug. GSK appealed the ruling, but settled last year without admitting any connection between the drug and the case.

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