Real-world pharmacovigilance study on neonatal congenital anomalies associated with maternal drug exposure using the FDA Adverse Event Reporting System.

Background: Congenital anomalies represent a significant public health concern, with maternal drug exposure during pregnancy being a potential modifiable risk factor. While certain medications, such as antiepileptics, are well-documented for teratogenic risks, the safety profiles of many other drug classes during pregnancy remain understudied. Objective: Leveraging the FDA Adverse Event Reporting System (FAERS), this study aimed to systematically evaluate associations between specific medications and neonatal (<28 days old) congenital anomalies potentially related to maternal drug exposure through large-scale pharmacovigilance analysis. Design: A retrospective pharmacovigilance study was conducted by comprehensively searching the FAERS database to identify drugs potentially associated with congenital anomalies. Methods: We reviewed all reports from the FAERS database from January 2004 to December 2022, using the criteria of age less than 28 days and outcomes of congenital anomalies. Signal detection methods, including the Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were employed to determine the associations between specific drugs and congenital anomalies, with a focus on potential teratogenic effects. Result: We reviewed 22,263,916 cases in the FAERS database and identified the association between 91 drugs and congenital anomalies, yielding 610 positive signals. Notably, specific drugs, including olanzapine and quetiapine among antipsychotics, valproate and topiramate among antiepileptics, sertraline, paroxetine, citalopram, escitalopram, and bupropion among antidepressants, and amlodipine and sartans among antihypertensives, exhibited higher teratogenic risks compared to their counterparts. Additionally, the use of omeprazole and metronidazole may lead to an increased risk of teratogenesis. Conclusion: Our research offers a thorough examination of teratogenic risks across different drug categories using data from the FAERS database, which can enhance the safety of medication use during pregnancy and inform clinical decision-making.