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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

New Study Links Paxil to Twice as Many Birth Defects as Other Antidepressants

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. “Healthcare professionals are advised to carefully weigh the potential risks and benefits of using [Paxil] in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients,” the FDA says in a news release. Paxil Linked to Twice as Many Birth Defects GlaxoSmithKline recently conducted a study of major birth defects in infants born to women who took antidepressants (including ... Read More