Safety alert
date: 9/29/2005
Paxil use may be risky during pregnancy
Women who are or may become pregnant should discuss risks and benefits with their doctor before taking an antidepressant.
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On September 27, 2005, the Food and Drug Administration and manufacturer GlaxoSmithKline added pregnancy precautions to prescribing information for the antidepressant paroxetine (Paxil and Paxil CR Controlled-Release Tablets). Preliminary results of a retrospective study of women taking antidepressants during the first trimester of pregnancy suggest an increased risk of major congenital malformations among infants born to those taking paroxetine compared to those taking other antidepressants. Health-care professionals were advised to carefully weigh the potential risks and benefits of using paroxetine therapy in pregnant women and to discuss these findings and treatment alternatives with their patients.
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