The US Food and Drug Administration today released an alert regarding use of the SSRI antidepressant Paxil (generic Paroxetine) during pregnancy. Two studies, one in Sweden and one in the United States, showed that when Paxil is used during the first three months of pregnancy there was a significantly increased risk of heart defects in the fetus. In the Swedish study, heart defects occurred twice as often with Paxil use than without - in 2% of births compared to 1%. In the US study, the rate of heart defects with Paxil was 1.5% compared to 1% with other antidepressants; when all birth defects were taken into account, the rate for Paxil use compared to other antidepressants was 1.8% greater.
Based on these results, the FDA urges physicians to consult with women patients taking Paxil who are pregnant or are of child-bearing age. The agency points out that the benefits of taking Paxil may outweigh the risks, and warns women not to discontinue Paxil except with the advice of their physicians and according to prescribing information, as serious side effects can occur when an SSRI antidepressant is discontinued abruptly. (For more, see SSRI Discontinuation Syndrome.)
The FDA has also asked GlaxoSmithKline, the manufacturer of Paxil, to strengthen the warning labels on prescriptions.
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