Fetal Congenital Cardiac and Vascular Disorders Associated with Sertraline Treatment during Pregnancy: Analysis of FAERS Data

OBJECTIVE: Sertraline is one of the most commonly used antidepressants worldwide and is one of the first-choice treatments for depression during pregnancy. This study is aimed at testing the possible association between sertraline intrauterine exposure and congenital cardiac and vascular disorder occurrences by assessing the publicly available US Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Disproportionality analysis and Bayesian analysis were used to mine FAERS for suspected congenital cardiac and vascular disorder data for sertraline intrauterine exposure from the first quarter of 2004 to the second quarter of 2021. RESULTS: Among the 914 cases of sertraline used with congenital cardiovascular disease in the FAERS database, the reporting areas were mainly in the United States and Europe. The number of adverse events reported every year since 2004 has no many differences. Congenital anomalies are the most frequently reported serious clinical outcome. Among the 69 positive signals detected from 914 cases, 31 were invalid signals, and 38 were valid signals according to criteria. The most common ones are heart disease congenital, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and persistent fetal circulation. CONCLUSIONS: Mining FAERS data can analyze and study the adverse reactions of sertraline in a more comprehensive and in-depth manner, thereby effectively reducing the risk of clinical medication.