Evaluating adverse events reported for non-steroidal anti-inflammatory drugs in osteoarthritis: a real-world pharmacovigilance study
Abstract
OBJECTIVE: Non-steroidal anti-inflammatory drugs (NSAIDs) have emerged as a critical therapeutic class for the management of osteoarthritis (OA). Nonetheless, there remains a notable deficiency in large-scale, real-world evidence regarding the safety profile of NSAIDs in individuals with OA. This study employed real-world drug monitoring methods to comprehensively assess the adverse events (AEs) reported by OA patients when using NSAIDs.
METHODS: This analytical study is grounded in AEs data systematically gathered through the FDA Adverse Event Reporting System (FAERS) surveillance program. The main focus of this study is to assess the AEs reported by OA patients when using NSAIDs. The analysis encompassed a range of commonly prescribed NSAIDs, including Ibuprofen, Naproxen, Diclofenac, Celecoxib, Rofecoxib, and Piroxicam, as commonly employed in clinical settings. The study spans a 20-year observation period, from the first quarter of 2004 to the fourth quarter of 2024. An unbalanced analysis method was adopted to investigate the AEs reported with the use of NSAIDs in OA patients, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Furthermore, the study delineated the relevant system organ categories (SOC) for the identified AEs, utilizing the FAERS database. A Time-to-Onset (TTO) analysis was also conducted to systematically evaluate the temporal…
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