OBJECTIVES

Tooth disorders are a group of conditions that include cavities, pulpitis, periapical abscess, impacted teeth and malocclusion. Denosumab is a RANK ligand inhibitor used in the treatment of bone loss in osteoporosis, breast cancer and prostate cancer in women and men respectively. This study aims to quantify the risk of tooth disorders associated with Denosumab using disproportionality analysis in USFDA Adverse Event Reporting System (FAERS).

METHODS

An analysis was performed using publicly available FAERS data. Signal strength was calculated by Reporting odds ratios (RORs) and Proportional reporting ratios (PRRs) with 95% confidence intervals (CIs). A value of ROR lower limit >1 and PRR >2, minimum 3 cases and chi square <4 indicates an association between drug and the adverse events.

RESULTS

FAERS database had a total of 14751 reports for tooth disorder. Amongst which, 2477(16.79%) reports were associated with Denosumab. Denosumab associated tooth disorders was found to have a signal strength of ROR:14.139(13.414-14.904) and PRR:13.93(13.225-14.673). Denosumab without concomitant drugs that are associated with tooth disorder was found to have a signal strength of ROR:17.40314(16.66245-18.17674) and PRR:17.11857. The minimum and maximum age was 32years and 98years respectively with signal strength of ROR:9.359; PRR:9.252 for adults, ROR:9.111; PRR:9.005 for geriatrics. Tooth disorder was mostly reported in females (81.27%) compared to males (9.77%) and gender not defined (1.01%) with the signal strength of ROR:11.039; PRR:10.875, ROR:17.198; PRR:16.993 and ROR:14.211; PRR:14.001 respectively.

CONCLUSIONS

The present showed an associated between Denosumab and Tooth disorder, while this adverse event is not identified in the pre-clinical trial or post-marketing data. Although a causal relation cannot be definitively proved, the number of cases reported suggests that there might be an association. Increased awareness of this risk among both prescribers and patients may help mitigate the number and severity of these adverse events.