CONGENITAL MALFORMATIONS AMONG NEWBORNS EXPOSED IN UTERO TO DIFFERENT ANTIDEPRESSANT CLASSES DURING PREGNANCY: A DESCRIPTIVE REAL-WORLD ANALYSIS OF ELECTRONIC MEDICAL RECORDS
Author(s)
Fatimah Alyami, BSPharm, MS, PhD.1, Pam Heaton, BSPharm, FAPhA, PhD.2, Ana L. Hincapie, MS, PhD3, Marepalli B Rao, MS, PhD4, Patricia Wigle, Pharm.D., BCPS, BCACP, FCCP3, Jeff Jianfei Guo, B.Pharm, PhD3.
1Center for Health Technology Assessment, Riyadh, Saudi Arabia, 2University of Toledo, Toledo, OH, USA, 3James L Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA, 4College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
1Center for Health Technology Assessment, Riyadh, Saudi Arabia, 2University of Toledo, Toledo, OH, USA, 3James L Winkle College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA, 4College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
OBJECTIVES: To describe the frequency and types of congenital malformations among newborns exposed in utero to different therapeutic classes of antidepressants, using real-world electronic medical records (EMR).
METHODS: Within an observational retrospective cohort of pregnant women with mental health disorders treated at University of Cincinnati Medical Center Hospitals (June 2012-November 2021), newborns exposed to antidepressants during pregnancy were identified using ICD-9/ICD-10 codes. Congenital malformations were ascertained from infant records and classified as major or minor; a single newborn could have more than one malformation. Frequencies were summarized descriptively by maternal antidepressant class: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclics, atypical antidepressants, multiple antidepressants, and monoamine oxidase inhibitors (MAOIs).
RESULTS: SSRIs were the most frequently prescribed class. Among 812 SSRI-exposed newborns, 140 (17.2%) had congenital malformations (242 malformations total); ankyloglossia was most common (29; 11%), followed by ventricular septal defect (10). Among 134 atypical-antidepressant-exposed newborns, 31 (23.1%) were affected (64 malformations), most commonly hypospadias, atrial septal defect, and patent ductus arteriosus. Among 63 SNRI-exposed newborns, 12 (19.0%) were affected (24 malformations); among 153 multiple-antidepressant-exposed newborns, 28 (18.3%) were affected (40 malformations); and among 28 tricyclic-exposed newborns, 6 were affected (9 malformations). The single MAOI-exposed newborn had none. Overall, 217 affected newborns were identified,111 with major, 4 with minor, and 102 with both most following third-trimester exposure (86.17%).
CONCLUSIONS: Across antidepressant classes, the proportion of exposed newborns with congenital malformations was broadly similar (approximately 17-23%), with ankyloglossia and cardiac defects (ventricular and atrial septal defects, patent ductus arteriosus) the most frequently reported anomalies. These descriptive, real-world findings characterize malformation patterns by class but cannot establish causation given the absence of an unexposed comparator and possible confounding. Comparative, adequately powered studies are warranted.
METHODS: Within an observational retrospective cohort of pregnant women with mental health disorders treated at University of Cincinnati Medical Center Hospitals (June 2012-November 2021), newborns exposed to antidepressants during pregnancy were identified using ICD-9/ICD-10 codes. Congenital malformations were ascertained from infant records and classified as major or minor; a single newborn could have more than one malformation. Frequencies were summarized descriptively by maternal antidepressant class: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclics, atypical antidepressants, multiple antidepressants, and monoamine oxidase inhibitors (MAOIs).
RESULTS: SSRIs were the most frequently prescribed class. Among 812 SSRI-exposed newborns, 140 (17.2%) had congenital malformations (242 malformations total); ankyloglossia was most common (29; 11%), followed by ventricular septal defect (10). Among 134 atypical-antidepressant-exposed newborns, 31 (23.1%) were affected (64 malformations), most commonly hypospadias, atrial septal defect, and patent ductus arteriosus. Among 63 SNRI-exposed newborns, 12 (19.0%) were affected (24 malformations); among 153 multiple-antidepressant-exposed newborns, 28 (18.3%) were affected (40 malformations); and among 28 tricyclic-exposed newborns, 6 were affected (9 malformations). The single MAOI-exposed newborn had none. Overall, 217 affected newborns were identified,111 with major, 4 with minor, and 102 with both most following third-trimester exposure (86.17%).
CONCLUSIONS: Across antidepressant classes, the proportion of exposed newborns with congenital malformations was broadly similar (approximately 17-23%), with ankyloglossia and cardiac defects (ventricular and atrial septal defects, patent ductus arteriosus) the most frequently reported anomalies. These descriptive, real-world findings characterize malformation patterns by class but cannot establish causation given the absence of an unexposed comparator and possible confounding. Comparative, adequately powered studies are warranted.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EPH140
Topic
Epidemiology & Public Health, Study Approaches
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Mental Health (including addiction), Pediatrics, Reproductive & Sexual Health