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The popular antidepressant drug Paxil has been linked to fetal heart malformations and should be avoided during pregnancy if possible, warns an American College of Obstetricians and Gynecologists advisory group.
While a few previous studies have yet to find a significant association between SSRI antidepressant use in pregnancy and serious congenital defects, the maker of Paxil, GlaxoSmithKline, has revealed that there exists unpublished reports indicating an increased risk of atrial and ventricular septal malformations when Paxil is used in the first trimester.
Swedish Study and U.S. Report
According to the results of an unpublished Swedish study, women who took Paxil during the first trimester of their pregnancy doubled the risk of birthing a baby with heart defects compared to women in the country''s registry population.
Furthermore, a U.S. report found that infants born to mothers who received Paxil early in their pregnancy had a 1.5-fold heightened risk of developing heart malformations and a 1.8-fold risk for birth defects compared with women who used non-SSRI antidepressants.
The findings of both studies were restricted to no other SSRIs other than Paxil.
Label Change
As a result of the U.S. study, the drug maker strengthened the label warning on Paxil to Category D—medications that may pose harmful effects on human fetuses.
However, the Ob/Gyn committee does not advise pregnant women to discontinue use of Paxil before speaking to a doctor.
“Decisions about treatment of depression should incorporate the clinical expertise of the mental healthy clinician and obstetrician, and the process should actively engage the patient''s values and perceptions when framing the discussion of the risks and benefits of treatment,” wrote the committee members.
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