ONE of Britain’s most widely prescribed antidepressants has been linked to a seven-fold increase in suicide attempts.

An analysis of trials for Seroxat involving more than 1,500 patients found seven suicide attempts among those taking the drug and only one among those taking a placebo. Suicidal thoughts were also commoner among those taking Seroxat (paroxetine), by a factor of three to one.

Almost 2.4 million prescriptions for the drug were issued in England last year.

The data was available even before Seroxat was first licensed in 1990, the Norwegian researchers found. The findings are likely to be seized on by lawyers attempting to win damages against the drug’s manufacturer, GlaxoSmithKline, in the US and in Britain. The mental health charity Mind said the results were “extremely worrying” and confirmed what it had been arguing for years.

“By ignoring what mental health service users themselves have said about the medication and its effects, the drugs regulators may well have caused lives to be lost,” said Sophie Corlett, policy director of the charity.

Campaigners, including Mind, say the drug should be withdrawn from sale, but GSK and the Medicines and Healthcare products Regulatory Agency (MHRA) have defended it, arguing that its benefits outweighed the risks.

However the MHRA has said that too many drugs of this class, SSRIs (selective serotonin re-uptake inhibitors), have been prescribed, and has warned that they should not be given to under-18s.

The MHRA also said that an increase in suicidal thoughts among users of Seroxat “cannot be ruled out.” The new study suggests that such an increase should have been apparent from the beginning.

Sales of paroxetine have fallen sharply in the UK in the past three years after concerns about it were highlighted by the media.

A team led by Ivar Aursnes of the University of Oslo looked at 16 studies in which paroxetine had been compared with placebo, including previously unpublished data.

The trials covered a total of 190 patient-years of use of the drug and the results were published in the journal BMC Medicine.

Ms Corlett of Mind said: “This study would seem to be an extremely worrying addition to growing evidence raising serious concerns over the safety of paroxetine.

“Mind's own research has revealed that 50 per cent of the people who contacted us to report a reaction to Seroxat had experienced feelings of wanting to self-harm or commit suicide, and 58 per cent of these people said they had not experienced these feelings before they started taking Seroxat.”

GSK said: “We will review this study carefully. However, these conclusions in no way reflect the picture that has been built up about the benefits and risks of paroxetine in adults through an extensive clinical trials programme involving 24,000 patients.”

The MHRA said that while a modest increase in suicidal thoughts and self-harm could not be ruled out for those on SSRIs, there was insufficient evidence to conclude that there is any marked difference between different SSRIs, or between SSRIs and other antidepressants.

The Norwegian group concluded: “The increased suicidal activity seen in children and adolescents on certain antidepressant drugs may well be present in adults. The restrictions in the use of paroxetine in children and adolescents conveyed by regulatory agencies lately should include usage in adults.”

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