Objective To explore the risk signals of osteonecrosis of jaw induced by
antiresorptive drugs and provide references for the clinical safety
application. Method Based on the Food and Drug Administration Adverse
Event Reporting System (FAERS) from January 2004 to June 2021, We chosen
‘Osteonecrosis of jaw’ as Preferred Terms (PT) and antiresorptive drugs.
We used proportional reporting ratio (PRR), odds ratio (reporting odds
ratio, ROR), Bayesian confidence propagation neural network (BCPNN) and
multi-item Gamma-Poisson contraction (MGPS) algorithm to evaluate the
association between drugs and adverse events. Results 27,065 reports
related to osteonecrosis of the jaw in the FAERS dated from January 2004
to June 2021 . A total of 9 antiresorptive agents were included in the
analysis. Affected patients tended to be older than 65 years. Most cases
were reported from North America (39.82%) and Europe (36.15%) and were
submitted by health-care professionals (81.44%). Pamidronate and
clodronic acid showed a higher score than the other agents in every
method. Zoledronic acid and denosumab were reported more than other
agents.. Rate of hospitalization due to antiresorptive-related
osteonecrosis of the jaw was from 7.66% to 28.78%; rate of fatality
was from 0 to 12.78%. Conclusion All antiresorptive drugs may cause
ONJ, and ONJ can be effectively prevented. Practitioners should consider
the factors that may increase the likelihood of ONJ. The findings
support a continued surveillance and risk factor identification studies.