Sublingual/Buccal buprenorphine and dental problems: a pharmacovigilance study

ABSTRACT

Background

The association between dental problems and sublingual/buccal buprenorphine is unclear. We conducted an analysis of dental adverse drug reactions reported with sublingual/buccal buprenorphine in VigiBase®, the pharmacovigilance database of the World Health Organization.

Research design and methods

We performed disproportionality analyses to compare the reporting rates of dental problems with sublingual/buccal buprenorphine, compared to other buprenorphine formulations and methadone. Significant signals were considered if the lower boundary of the 95% confidence interval of the Reporting Odds Ratio (ROR) was > 1; cases were ≥ 3 and p-value <0.05. We conducted sensitivity analyses by calculating the ROR according to the reporter’s qualification and the reporting continent (United States of America and Europe).

Results

We included 30,769 reports with all buprenorphine forms. We found 20 cases of dental problems with sublingual/buccal buprenorphine. Sublingual/buccal buprenorphine was associated with an overreporting of dental problems compared to other buprenorphine formulations (ROR = 15.10; 95% CI [7.50–30.39]; p < 0.005) and compared to methadone (ROR = 6.02; 95% CI [3.21–11.30]; p < 0.005). Overreporting of dental problems was consistent in sensitivity analyses, except in Europe compared with other buprenorphine formulations and with methadone.

Conclusions

Sublingual/buccal buprenorphine might increase the risk of reporting dental problems. However, these results do not modify the benefits of sublingual/buccal buprenorphine in the treatment of opioid use disorders.

KEYWORDS:

• Buprenorphine
• dental problems
• oral health pharmacovigilance
• methadone
• opiate substitution treatment

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer has previously completed osteoarthritis research (2019–21) which was supported by Pfizer and Eli Lilly. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author Contribution statement

All authors significantly contributed to this work. R Barus drafted and wrote the manuscript. F Montastruc, M Lapeyre- Mestre, and C de Canecaude, substantially revised the manuscript. H Bagheri, A Sommet and M Lapeyre-Mestre critically reviewed the manuscript.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2247962

Additional information

Funding

This paper was not funded.