Data fail to link paroxetine to birth defects
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Depressed women of child-bearing age need reassurance from future
studies |
A study by German researchers has failed to show that paroxetine causes congenital abnormalities.
The data from a prospective study of 119 women who had taken paroxetine
during early pregnancy and 645 controls were presented at the European
Society of Human Reproduction and Embryology annual conference in Prague
this week.
The rate of congenital malformations was not increased in the paroxetine
group compared with the control group (3.4 per cent versus 4.5 per cent;
relative risk 0.76, 95 per cent confidence interval 0.18–2.53).
The three abnormalities reported in the paroxetine group were a clubfoot,
a large port-wine stain and a condition involving painful spasms of the
neck. The rate of elective terminations of pregnancy was higher in the
paroxetine group (15.1 per cent versus 2.6 per cent; P<0.001).
The researchers point out that a warning issued by the US Food and Drug
Administration last year that use of paroxetine could increase the risk
of major congenital abnormalities was based on unpublished data and did
not include controls. They conclude that further data should be collected
to reassure patients of a fertile age who need long-term antidepressant
therapy. |
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