Risk of Congenital Anomalies Associated with Psychotropic Medications: A Review of Neonatal Reports in the FDA Adverse Event Reporting System (FAERS)

Abstract

Purpose The objective of this article is to explore commonly prescribed psychotropic medications, such as atypical antipsychotics (AAs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), regarding their potential association with congenital anomalies in newborns. This analysis will be based on data obtained from the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods Spontaneously reported cases involving congenital anomalies in newborns (under 28 days old) were extracted and reviewed from the FAERS database covering the period from January 2004 to June 2023. We employed four methods (ROR, PRR, BCPMM, MGPS) to identify signals associated with neonatal deformities caused by specific drugs in newborns. Results The FAERS database encompassed 21,605 reported cases involving newborns, of which 6,208 reported congenital abnormalities. Among these cases, 6,164 (99.29%) explicitly attributed the adverse event to the drug. Following calculations utilizing four signal detection methods, the top ten psychiatric drugs associated with congenital abnormalities in newborns were Venlafaxine, Quetiapine, Olanzapine, Sertraline, Citalopram, Mirtazapine, Duloxetine, Paroxetine, Aripiprazole, and Fluoxetine. These drugs demonstrated heightened signal frequencies concerning heart disease, neurological disorders, respiratory-chest-mediastinal conditions, and musculoskeletal-connective tissue disorders. Conclusions The use of psychotropic medications during pregnancy has been observed to correlate with the potential risk of specific congenital abnormalities. Pregnant women with psychiatric disorders are advised to use psychotropic drugs with caution. Healthcare professionals should actively understand the potential risks of specific psychotropic medications in causing particular congenital abnormalities, enabling them to provide informed counseling and explore more suitable treatment options for patients.