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MHRA warning over paroxetine

By Emma Wilkinson

The UK drug regulator has issued a warning over the use of paroxetine (Seroxat) in pregnancy after the latest in a clutch of recent studies linked the drug to birth defects.

Swedish researchers found paroxetine taken in the first trimester ­ but not other SSRIs ­ appeared to double the risk of congenital malformation.

It follows data released by GlaxoSmithKline in October showing paroxetine increased birth defects compared with other SSRIs.

'Until this issue is further investigated, consideration should be given as to whether paroxetine is the most suitable SSRI in pregnant women or those planning to become pregnant,' the Medicines and Healthcare Products Regulatory Agency said.

The MHRA said it would be carrying out further investigations as a 'matter of urgency'.

Its letter to health professionals also cited Danish

research ­ revealed by Pulse in September ­ linking use of

SSRIs to congenital, particularly cardiac, malformations.

Professor Gordon Duff, chair of the MHRA's Commission on Human Medicines, said paroxetine should only be used in pregnancy 'if the benefits for the mother are thought to outweigh the potential risk to the foetus'. He advised gradual withdrawal of the drug over a number of weeks.

But prescribing experts complained the advice didn't go far enough and warned GPs to be cautious of using the drug in any woman of childbearing age.

Dr Brian Crichton, honorary lecturer in therapeutics and pharmacology at the University of Warwick and a GP in Solihull, Birmingham, said: 'My feeling is that we should think very carefully before prescribing paroxetine in women of childbearing age.

'It's difficult to look at changing medication in patients with depression and the bottom line is to try and not get into that position.'

Researchers assessed data on 958 children in the Swedish Medical Birth Register whose mothers reported paroxetine use in early pregnancy between 1995 and 2003.

The rate of congenital cardiac defects was 2.1 per cent compared with 1.1 per cent in the general population ­ close to the figures in the GSK study. No link with cardiac defects was found with other SSRIs.

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