Introduction: Fetal cardiac safety of sertraline is controversial even though it is among the most frequently used antidepressants in pregnancy. Sertraline could theoretically affect the fetal heart resulting in malformations or more subtle changes, but studies evaluating fetal cardiac safety are prone to a number of systematic and random errors.
Areas covered: The objective of this review is to evaluate the fetal cardiac safety profile of sertraline in pregnancy. A literature review included articles until November 2022 in Medline with no time or language limitations.
Expert opinion: Sertraline is associated with septal heart malformations, but not with more severe heart malformations. The association may be causal or at least partly related to systematic errors, including confounding by indication. Regardless of the causal mechanism, the association should not limit well-indicated treatments of maternal depression. The few available studies on fetal heart function is reassuring. There are no human data on the long-term effects on offspring cardiac function, but the teratogenic and fetal heart function studies do not imply risks of any major cardiac problems later in life. Interactions with other medication may, however, alter the risks associated with any medication in pregnancy, and information and surveilence systems taking this into account is much needed.
Keywords: Antidepressants; SSRI; cardiac function; cardiac malformations; drug safety; pregnancy; sertraline; teratology.