The FDA has notified healthcare professionals and the public on the use of SSRIs by women during pregnancy and the potential risk of persistent pulmonary hypertension of the newborn (PPHN). This condition occurs when a newborn baby does not adapt to breathing outside the womb. Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death.

This risk was first highlight in 2006 based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN. Following a review of these data, the FDA has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link. It will update the SSRI drug labels to reflect the new data and the conflicting results.