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The parents of a two-year old boy have filed a lawsuit against the maker of Paxil, alleging that the mother’s use of the antidepressant during pregnancy cause her son to be born with severe heart defects.
The U.S. Food and Drug Administration (FDA) recently announced that early research studies with the drug Paxil (paroxetine) suggest that taking the drug during the first three months of pregnancy may increase a woman’s risk of having a baby with birth defects, particularly heart defects.
The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paxil is approved for the treatment of depression and several other psychiatric disorders. FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil.
The Food and Drug Administration said Thursday that the warning label on GlaxoSmithKline’s widely-prescribed anxiety drug Paxil has again been revised to advise the drug may cause heart defects in babies.
