Exposure to Paxil in the first trimester of pregnancy may increase the risk at birth for "congenital malformations", physical defects present at birth that can involve the brain, heart, lungs, liver, bones, or intestinal tract. Congenital malformations are currently the leading cause of infant deaths in the U.S.; some examples include heart defects, cleft lip, cleft palate, Down syndrome, spina bifida, or limb defects.
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Paxil has been in the news before. There have been complaints of severe withdrawal symptoms, risks of suicidal behavior and increased violence in children and adolescents. GlaxoSmith Kline, the manufacturer of Paxil, says it is waiting for final results of the studies to "better understand the birth defect risk."
A joint study conducted by the FDA and the maker of Paxil reviewed medical records of 3,581 infants born to women who took Paxil or other antidepressants during the first trimester of pregnancy. A preliminary analysis found infants born to women who took Paxil were more likely to be born with an abnormality than babies born to women who took another antidepressant.