Abstract
In the fall of 2005, GlaxoSmithKline called attention to recently collected safety data indicating an increased risk of major congenital malformations among infants exposed during organogenesis to GlaxoSmithKline's selective serotonin reuptake inhibitor (SSRI), paroxetine. Among 527 fetuses exposed to paroxetine in the first trimester, 23 were born with major congenital malformations. Most of the malformations were cardiovascular, and the majority of those were ventricular septal defects. As compared with infants born to women taking any other antidepressant agent during the first trimester, the adjusted odds ratio for any malformation was 2.2 (95% confidence interval [CI], 1.3 to 3.6). Previously published . . .
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