The FDA and GlaxoSmithKline have alerted physicians about a new study on birth defects in babies born to women who took the antidepressant paroxetine (Medication Paxil) during the first trimester of pregnancy. In a study of more than 3,500 pregnant women, paroxetine was linked to twice as many major birth defects as other antidepressants, according to the FDA.
Birth defects are rare in the U.S., and it is not certain what role, if any, the drug might have played, notes GlaxoSmith-Kline. Most of the defects were related to the heart. In this retrospective epidemi-ological study, there were no data on birth defects in babies born to women who did not take antidepressants during early pregnancy.
Some studies of paroxetine canadian during pregnancy have suggested an increased risk of fetal malformations, but others have not.
Antidepressants have been linked to withdrawal symptoms in babies born to mothers taking selective serotonin re-uptake inhibitors (SSRIs).
Health care professionals are being advised to weigh the potential risks and benefits of using this drug in pregnant women and to discuss these findings as well as treatment alternatives with their patients. Patients should tell their doctors if they are pregnant, plan to become pregnant, or are breast-feeding.
GlaxoSmithKline will include the results of the study in the list of precautions on the drug’s product labeling.