Studying Medication Safety in Pregnancy: A Call for New Approaches, Resources, and Collaborations.

Abstract

In this month’s issue of Pediatrics , Bandoli et al1 report the results of their study, “Prenatal Antidepressant Use and Risk of Adverse Neonatal Outcomes,” in which they examine important outcomes, including congenital malformations and preterm delivery, in relation to in utero antidepressant exposure. The topic matters because 14% to 23% of pregnant women experience depression,2 and many struggle with decisions about whether to take medications because of incomplete and conflicting information about fetal risks. More broadly, given that the vast majority of pregnant women take at least one medication,3 we know concerningly little about the impact of these exposures on children, both short- and long-term. Although Bandoli et al1 have conducted a thorough and thoughtful study, their article also illuminates key challenges in this field. To answer critical questions about medication exposures in pregnancy, we need to assemble substantially larger databases than most researchers have successfully constructed thus far. Typical “large” studies in this field often start with a cohort of 600 000 to 2 million births.4–6 Although large, these sample sizes may not be … Address correspondence to Sascha Dublin, MD, PhD, Kaiser Permanente Washington Health Research Institute, 1730 minor Ave, Suite 1600, Seattle, WA 98101. E-mail: sascha.dublin{at}kp.org