Tagged Articles

Food and Drug Administration 233 articles

FDA Advising of Risk of Birth Defects with Paxil

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.  FDA is advising health care professionals to discuss ... Read More

FDA strengthens pregnancy warning on Glaxo’s 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. According to an agency release, two clinical studies have now indicated that pregnant women who take Paxil early in their pregnancy run about a 1.5% to 2% risk of bearing a child who has a hole in their heart. Expectant mothers who didn’t take the drug ran about a 1% risk. The extent of the heart defects ranged from mild to those that were severe enough to require surgery. ... Read More

New Paxil Labeling Warns Of Birth-Defect Risk

Preliminary study data suggest that the antidepressant paroxetine should not be prescribed to pregnant women. GlaxoSmithKline (GSK) late last month notified health care professionals that it was strengthening product label warnings advising against the use of paroxetine (Paxil, Paxil CR) by women who are pregnant. The company cited newly analyzed data from a retrospective epidemiologic study of major congenital malformations in infants, saying that “preliminary results suggest an increase in the risk of congenital malformations associated with the use of paroxetine as compared to other antidepressants.” Changes in the drug’s labeling are being made after consultation with the U.S. Food ... Read More