Objectives: The use of Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) during pregnancy is a controversial issue as SNRIs can affect the development of the fetus negatively. There is relatively limited information regarding the impact of SNRIs among women during their pregnancy. The objective of the study was to describe the most commonly reported pregnancy adverse events (AEs) related to SNRIs as reported in the FDA Adverse Event Reporting System (FAERS) database.

Methods: The primary data source was the publicly available FAERS database. The study design was a retrospective descriptive study from 2012 to 2021. Number of pregnancy related adverse events AEs was calculated for each SNRI. Analysis was performed for six groups of MedDRA Preferred Terms (PTs) - Spontaneous Abortion, Induced Abortion, Stillbirth, Congenital Malformation, Ectopic Pregnancy, and Low Birth Weight. Descriptive statistics was used to describe number of pregnancy adverse events AE reports and most frequently reported pregnancy adverse events.

Results: The total number of pregnancy related adverse events for all SNRI included in the study was (3618); Venlafaxine (2514), Duloxetine (1064), Desvenlafaxine (36), Milnacipran (4) and Levo-milnacipran (2). The most commonly reported pregnancy related AEs was congenital malformation (2377, [65%]) followed by spontaneous abortion (920, [25%]) and low birth weight (140, [3.9%]). The least common pregnancy related AE was stillbirth followed (82, [2.3%]) by ectopic pregnancy (20, [0.5%]). There were 613 patients outcomes associated with pregnancy related AEs, including 110 (18%) deaths, 60 (9.8%) disability, 274 (44.7%) hospitalizations and 169 (27.6%) life-threatening events. Out of 613 outcomes , 80% (496) outcomes were represented by congenital malformation AEs involving the usage of Venlafaxine, Duloxetine and Desvenlafaxine.

Conclusions: Therapeutic risk management is crucial for SNRI use during pregnancy since they are considered as high-risk population. Further studies are warranted to establish a causal relationship between SNRI use and pregnancy related AEs.