In September 2005, GlaxoSmithKline (GSK) sent a “Dear Doctor” letter to physicians notifying them of the results of a retrospective epidemiologic study suggesting an increased risk of congenital malformations in infants born to mothers who ingested Paxil in the first trimester of pregnancy as compared to other antidepressants. GSK changed the Pregnancy subsection of the Precautions section of the Paxil label to reflect the new information.
On December 8, 2005, after the results of a second study became available, the FDA issued a Public Health Advisory to health care professionals and patients advising them that Paxil should not be taken by women who were pregnant or planned on becoming pregnant. In one study, women taking Paxil in the first trimester had a two-fold increased risk for having an infant with a cardiac defect.
In another study, infants of women who received Paxil in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations. As a result, the FDA requested GSK to change Paxil’s pregnancy category from C to D and to add additional information to the Warning section of the Paxil label. The Category D warning, which is a stronger warning, means that studies in pregnant women have demonstrated a risk to the fetus.
On July 19, 2006, the FDA issued a Public Health Advisory for Paxil and several other antidepressants advising of the results of a study published in the New England Journal of Medicine showing a six-fold increased risk of persistent pulmonary hypertension (PPH) in infants born to mothers who took an antidepressant in the last trimester of pregnancy. Lawyers in our firm’s Mass Torts Section continue to review Paxil-related birth defect cases. For more information on this subject contact Roger Smith at Roger.Smith@beasleyallen.com or 800-898-2034.
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