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GlaxoSmithKline and the U.S. Food and Drug Administration are warning healthcare professionals that a study has linked Paxil to double the risks of serious birth defects among infants born to women taking Paxil during the first trimester of pregnancy compared with other antidepressants.
A long-term epidemiological study suggested Paxil had an overall higher risk of major congenital malformations compared to other antidepressants. The FDA said healthcare professionals, as a result of the study’s findings, should carefully weigh potential risks and benefits of Paxil in women during pregnancy.
Labeling for Paxil, and other antidepressant drugs, already include warnings of the possible risks for birth defects. Paxil is classified as a “Category C” drug for pregnant women, which means comprehensive studies of its effects on pregnancy have not been performed.
In August, Norwegian researchers said Paxil is associated with a higher risk of suicide in adults.
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