FDA Warns of Neonatal Pulmonary Hypertension Risk with SSRIs When Used in Pregnancy

The FDA has notified healthcare professionals that the use of selective serotonin reuptake inhibitors (SSRIs) by women during pregnancy may be associated with a potential risk of persistent pulmonary hypertension of the newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study by Chambers et al. that found a six-fold increase in PPHN among neonates whose mothers were exposed to an SSRI after 20 weeks of gestation. 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.

The FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN. The FDA will update the SSRI drug labels to reflect the new data and the conflicting results. Healthcare professionals are advised not to alter their current clinical practice of treating depression during pregnancy.

SSRIs are indicated in the treatment of depression, anxiety, and obsessive-compulsive disorder and include Celexa (citalopram; Forest); Lexapro (escitalopram; Forest); Prozac, Sarafem (fluoxetine; Eli Llly, Warner Chilcott); Symbyax (olanzapine/fluoxetine; Eli Lilly); Luvox CR (fluvoxamine; Jazz); Paxil, Paxil CR, and Pexeva (paroxetine; GlaxoSmithKline, Noven); Zoloft (sertraline; Pfizer); and Viibryd (vilazodone; Forest).

For more information, visit www.fda.gov/Drugs/DrugSafety/ucm283375.htm.