BISPHOSPHONATES AND OSTEONECROSIS: ANALYSIS OF THE KOREA ADVERSE EVENT REPORTING SYSTEM

OBJECTIVES: To examine if bisphosphonate (BP) use is associated with drug related osteonecrosis (osteonecrosis) using adverse drug reaction (ADR) data reported in the Korea Adverse Event Reporting System (KAERS) from 2013 to 2015. METHODS: The KAERS database contained a total of 754,231 ADR reports from 38,974 patients, resulting in an average of 1.99reportsperpatient; the ADR reports include patient demographics, concomitant drugs, patients' outcomes, reaction severity, reporting centers, and the results of causality assessments. The reporting odds ratio (ROR) was calculated to estimate the association between osteonecrosis and implicated medications. Chi-square tests were also conducted to compare the sociodemographic characteristics of osteonecrosis patients who reported BP use to those using other drugs. RESULTS: 230 ADR reports involving osteonecrosis cases were identified from the total 754,231 ADR reports. Among the 230 osteonecrosis reports, 201 reports (87.4%) were attributed to BP use, while 27 reports (11.7%) were attributed to other drug use; 2 reports lacked drug information. The ROR for osteonecrosis and BP use was 82.57 (95%CI, 55.06-123.82), with a majority of cases (n=105) associated to alendronate use among the six different classes of BP. Among the 228 reports of osteonecrosis, females (n=167, 87.6%) were more likely to report BP-related osteonecrosis than males (n=24, 12.6%) (p< 0.001). Concomitant medications that were used with BP were rare and included Amlodipine, Calcitriol, Risedronate and Tiotropium bromide (each. n=3, 7.5%). CONCLUSIONS: The risk of BP use for drug related osteonecrosis in ADR reports in South Korea were examined. The results imply that BP use needs to be carefully monitored for patients with susceptibility for osteonecrosis.