From common to unreported: a real-world study of adverse events to duloxetine in the treatment of osteoarthritis.

BACKGROUND In a review of drug guidelines published by the International Association for the Study of Osteoarthritis, it is recommended to support the conditional use of duloxetine in patients with osteoarthritis. However, there is a lack of comprehensive research on the adverse events of duloxetine for the treatment of osteoarthritis populations. RESEARCH DESIGN AND METHODS We used the reporting odds ratio (ROR) to determine the strength of the adverse event signal. In addition, we investigated trends in the occurrence of adverse events using the Weibull shape parameter (WSP) test. RESULTS The results showed that 50 and 14 adverse events were detected in both Asian and American populations. Four new adverse events, Mouth ulceration, femoral neck fracture, incontinence, long QT syndrome, were identified. There was a difference in the time of adverse event induction between the North American and Asian populations (p < 0.0001). The Weibull shape parameter (WSP) test showed that the incidence of AE decreased over time. CONCLUSION Our study contributes to an in-depth understanding of the safety of duloxetine in the treatment of osteoarthritis.