Antibiotic safety signals in Saudi Arabia: A pharmacovigilance study using disproportionality analysis

Antibiotics are one of the most commonly reported drugs that can potentially lead to adverse events that pose a significant public health challenge due to increased morbidity and mortality. Therefore, monitoring the safety of marketed and authorized antibiotics is vital for maintaining public health and reducing the economic burden.

A comprehensive observational national study that analyzed spontaneous reports of ADEs collected from the Saudi FDA's Vigilance Database from 2019 to 2023, and we further applied the Bayesian Confidence Propagation Neural Network (BCPNN) method to identify potential safety signals.

The dataset comprised 77,763 ADE reports associated with 16 antibiotic classes. The higher proportion of patients experiencing ADEs was males (57.7%) compared to females (42.1%). The disproportionality analysis revealed that almost all antibiotics were associated with specific events, underscoring the importance of active monitoring. Amoxicillin was the most frequently reported antibiotic, accounting for 15.01% of the reported ADEs, followed by cefuroxime at 12.62%, vancomycin at 8.56%, and meropenem at 8.34%.

This study provided a comprehensive overview of antibiotic-related ADEs and emphasized the importance of monitoring patients receiving antibiotics for signs and symptoms of adverse events, as they continue to pose a threat. Moreover, it revealed strong signals of preventable adverse events, highlighting the need to enhance patients' quality of life and healthcare management.