In the fall of 2005, GlaxoSmithKline called attention to recentlycollected safety data indicating an increased risk of majorcongenital malformations among infants exposed during organogenesisto GlaxoSmithKline's selective serotonin reuptake inhibitor(SSRI), paroxetine. Among 527 fetuses exposed to paroxetinein the first trimester, 23 were born with major congenital malformations.Most of the malformations were cardiovascular, and the majorityof those were ventricular septal defects. As compared with infantsborn to women taking any other antidepressant agent during thefirst trimester, the adjusted odds ratio for any malformationwas 2.2 (95% confidence interval [CI], 1.3 to 3.6). Previouslypublished . . . [Full Text of this Article]
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From the Division of Maternal–Fetal Medicine, Massachusetts General Hospital, Boston.
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