The FDA reccommends that pregnant women be warned about the dangers of Paxil in pregnancy after the preliminary results of two studies showed that the rate of heart defects in babies born to women taking Paxil was 2% compared to the 1% from a general population. This increase in the risks of birth defects from taking Paxil has promted the FDA to discourage women from taking Paxil at all during pregnancy, requesting that they switch to another medication under advice from their doctors. They also remind women that they should not suddenly stop taking Paxil, though this choice is ultimately up to a woman and her doctor.
The Food and Drug Administration says that preliminary data suggest that there is double the rate of birth defects, specifically heart defects, in babies born to mothers who took Paxil in the first three months of pregnancy.
Paxil (Paroxetine, Paxil CR, Pexeva, and generic paroxetine hydrochloride.) is approved as an anti-depressant. Previously the Food and Drug Administration had it listed a a Category C drug in pregnancy, now they want GlaxoSmithKlein to label it as a Category D drug, meaning that the drug has known effects on a fetus, but that the benefits may still outweigh that risk.
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12/9/05
