Medication Monitor

Generic Name (Trade Name—Company)
December 15, 2011

Selective serotonin reuptake inhibitors

(Multiple products—Multiple manufacturers)
Neonatal pulmonary hypertension with use in pregnancy

Persistent pulmonary hypertension of the newborn (PPHN) may be associated with use of selective serotonin reuptake inhibitors (SSRIs) by women during pregnancy. However, the data are conflicting, making it difficult to draw definite conclusions about this association, according to an FDA safety communication.

Initial data reviewed in July 2006 noted that exposure to SSRIs after 20 weeks' gestation was associated with a six-fold increase in PPHN among neonates. Since then, analyses of more recent data have produced conflicting results, with some studies showing an increased risk and others not.

The agency noted that it will be updating SSRI drug labels to include this information. At this time, FDA does not advise clinicians to alter their current clinical practice of treating depression during pregnancy.