Selective Serotonin Reuptake Inhibitor (SSRI)
January 6, 2012
FDA has announced that it is unclear whether there is a correlation between mothers who use selective serotonin reuptake inhibitor (SSRI) antidepressants during pregnancy and development of persistent pulmonary hypertension of the newborn (PPHN) in their newborns. Newborns with PPHN have difficulty breathing outside the womb and may require intensive care support. FDA has not found sufficient evidence to conclude that SSRIs cause PPHN as two studies showed an increased risk and three studies did not show a correlation.
FDA recommends that healthcare professionals continue current prescribing practices of SSRIs in pregnant women and report all adverse events to the FDA MedWatch program. Weigh the risk of depression in women during pregnancy against a small possible risk of PPHN in their newborns. Depression, if untreated during pregnancy, may lead to low birth weight, preterm delivery, failure to recognize and report signs of labor, and other poor outcomes. The American Psychiatric Association and American College of Obstetricians and Gynecologists publish guidelines for treatment of depression during pregnancy. Current SSRI product labeling warns of an increased risk of PPHN in infants exposed to SSRIs during pregnancy. The labeling will be updated to include the conflicting results of the new data.
Additional information can be obtained at the following links:
- FDA News Release:
- FDA Drug Safety Communication:
- Report on the management of depression during pregnancy:
January 6, 2012; December 15, 2011; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.