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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.
Preliminary study data suggest that the antidepressant paroxetine should not be prescribed to pregnant women.
The FDA and the drug company GlaxoSmithKline are alerting doctors about a new study on major birth defects seen in babies born to women who took the antidepressant Paxil during the first trimester of pregnancy.
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