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.