Buprenorphine Use and the Risk of Dental Adverse Events in Patients with Opioid Use Disorder.

Background:The US Food and Drug Administration (FDA) issued a drug safety communication warning of dental-related adverse events (DAE) reported in patients using buprenorphine films or tablets in January 2022. This study utilized more recent data with a broader dental outcome definition beyond what has been previously reported to provide comprehensive evidence of this risk. Objective:Assess the association between buprenorphine use and the risk of DAE among opioid use disorder (OUD) patients. Design:A retrospective cohort study. Methods:Using the Veradigm-MarketScan® linked dataset, adults aged ⩾18 years with an OUD diagnosis between June 30, 2018, and July 1, 2023, and who met our selection criteria were included. Patients were grouped as: (1) BUP users and (2) non-BUP users (control group). We used Prescription Time Distribution Matching (PTDM) and Inverse Probability Treatment Weighting (IPTW) methods to balance potential confounders between the 2 groups. The primary outcome was dental-related adverse events (DAE). Cox proportional hazards models estimated adjusted hazard ratios (HRs). Results:A total of 14 495 OUD adult patients were included. Of these patients, 4199 (28.97%) initiated oral buprenorphine. Among the overall population, most were males, 8742 (60.3%), with an average age of 44.9 years. The absolute risk of DAE was slightly higher among buprenorphine users (2.17%) compared to controls (1.66%). We found an increased risk of DAE in buprenorphine users compared to the control group (adjusted HR, 1.36; 95%CI, 1.04-1.78). Conclusions:There is an increased risk of DAE among buprenorphine users compared to non-users after 6 months of follow-up. Although this risk is modest, this finding suggests the need for increased awareness and preventive interventions among these users.