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Regulator 'ignored' drugs research claim

Posted: 25 August 2005 | Subscribe Online


The UK medicines regulator ignored evidence that antidepressants can make adults prone to suicide, a scientist has claimed.

Dr Ivar Aursnes, of the University of Oslo, said the Medicines and Healthcare products Regulatory Agency (MHRA) showed "no interest" last year in his initial findings that paroxetine, a class of SSRI (selective serotonin reuptake inhibitor) that includes the drug Seroxat, could increase suicidal tendencies among adults as well as children.

This week he published a report claiming that people taking the drug were seven times more likely to attempt suicide than those taking a placebo. The MHRA said it would review the evidence, but for now its advice on SSRIs remains the same.
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In 2003 it ruled that every SSRI bar Prozac was unsafe for under-18s. But last year, after a lengthy investigation, it decided there was "insufficient evidence" that adults were affected in the same way.

Aursnes claimed data supplied by GlaxoSmithKline (GSK) from clinical trials of patients taking Seroxat did not separate those who had attempted suicide from those contemplating suicide.
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He said he had contacted the MHRA during its investigation, telling it of his concerns and requesting the trial data, but was in effect ignored. He later acquired the data from the Norwegian authorities.

The MHRA denied it ignored Aursnes's approach.

GSK said the study was no more than a sub-analysis based on data collected 15 years ago.


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