EU rejects widow’s complaints over Seroxat risk concerns

Source: Irish Examiner

Hat tip to Stuart for sending me this.

EU rejects widow’s complaints over Seroxat risk concerns

By Seán McCárthaigh

THE European Ombudsman has rejected complaints by the widow of a Corkman who died by suicide that EU bodies failed to adequately review concerns she raised about the safety of the anti-depressant drug, Seroxat. However, the ruling only came after the European Commission and the European Medicines Agency (EMEA) addressed warnings by the EU ombudsman that they had possibly been guilty of maladministration in their dealings with Nuria O’Mahony.

The nurse from Bandon, Co Cork, maintains that her husband, Niall, 39, took his own life as a result of taking Seroxat. The father-of-three was found dead on December 26, 2003 — within two weeks after he first began taking the controversial drug.

Ms O’Mahony, a nurse at Cork University Hospital, complained to the European Ombudsman in 2005 there was a lack of information by the commission and the EMEA when she questioned their decisions to authorise the use of Seroxat.

A month earlier, the commission instructed EU states that Seroxat information should include a warning about its use in children and adolescents.

However, it ruled that the benefit-risk balance of the drug remained favourable for use by adults.

Ms O’Mahony said GlaxoSmithKline failed to release all its clinical trial data on Seroxat to medical licensing authorities and complained the commission and EMEA had failed to inform her how much of this data had been seen before they issued their recommendations.

She also claimed they had not given her a fair hearing on her concerns about the safety and suicide risks of Seroxat

Yesterday, she expressed gratitude for the help from the EU Ombudsman which resulted in the commission providing information which she had not previously been given.

“However, many questions remain unanswered about the safety of Seroxat and what steps the EU authorities have taken to see all available data on the drug,” said Ms O’Mahony.

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