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Since December 2005, the FDA has issued three Public Health Advisories about the risk of birth defect linked to Paxil use during pregnancy. The results of two studies demonstrated that women who used Paxil during the first trimester of pregnancy were 1.5 to 2 times as likely to deliver a baby with a heart defect, compared to women who didn’t use any antidepressant during pregnancy. There is also concern that use of Paxil late in pregnancy may be linked to short-term complications in newborns. This information has led to lawsuits against GlaxoSmithKline, the maker of Paxil. These lawsuits argue that GSK failed to adequately warn doctors and patients about the serious risks of using Paxil during pregnancy.

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