Abstract
Medication-related osteonecrosis of the jaw (MRONJ) is a rare and severe adverse drug reaction (ADR) commonly seen in people taking drugs prescribed for metastatic cancer and osteoporosis. Prior studies only analyzed this ADR utilizing the public database Food and Drug Administration Adverse Event Reporting System (FAERS) by different stages (2010-2014, 2015-2021); a more comprehensive study is needed to analyze the MRONJ cases and the associated drugs from a longer time span. We conducted a retrospective pharmacovigilance analysis for all reported MRONJ cases between 2010 and 2023 in FAERS, using preferred terms and the primary suspect drug as searching conditions. Thus, this study aimed to analyze the MRONJ cases and the associated drugs more comprehensively. The reporting odds ratios (RORs) and 95% CIs were calculated for each queried drug. To distinguish the signal levels, we calculated the expected information component (EIC) and its 95% CI, using the Bayesian confidence propagation neural network (BCPNN) methods. We identified 22 846 MRONJ cases. A total of 15 drug classes including 30 suspect drugs showed different positive signal levels; among these drugs, 8, 5, and 17 had strong, medium, and weak intensity signals (+++, ++, and +), respectively. Drug classes involved bisphosphonate, RANKL inhibitor, radiotherapy drug, monoclonal antibody for cancer, corticosteroid, tyrosine kinase inhibitor, mammalian target of rapamycin inhibitor, aromatase inhibitor, cyclin-dependent kinase 4/6 inhibitor, immunomodulator, microtubule inhibitor, selective estrogen receptor modulator, sclerostin monoclonal antibody, estrogen receptor antagonist, and cytotoxic drug. Bisphosphonate, RANKL inhibitor, and radiotherapy drug exhibited higher risk than other classes with higher ROR or EIC 95% CI lower limit. Females had higher MRONJ incidence than males, and the mean age was 67.33 ± 11.71 yr. Compared with previous research, this study identified more drug classes and more novel medications with positive MRONJ signals that warrant further attention.