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Sublingual/Buccal buprenorphine and dental problems: a pharmacovigilance study
Romain Barus1, François Montastruc1, Claire de Canecaude1
1Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, Toulouse, France.
Expert Opinion on Drug Safety
|August 16, 2023
Summary
Sublingual/buccal buprenorphine use may be associated with an increased risk of dental problems. This finding does not alter the established benefits of this medication for treating opioid use disorders.
Area of Science:
- Pharmacovigilance
- Dental Adverse Drug Reactions
- Opioid Use Disorder Treatment
Background:
- The relationship between sublingual/buccal buprenorphine and dental issues remains unclear.
- An analysis of dental adverse drug reactions was conducted using VigiBase®, the WHO pharmacovigilance database.
Purpose of the Study:
- To investigate the potential association between sublingual/buccal buprenorphine and dental problems.
- To compare the reporting rates of dental issues with sublingual/buccal buprenorphine against other buprenorphine formulations and methadone.
Main Methods:
- Disproportionality analyses were performed using Reporting Odds Ratios (ROR).
- Significant signals were identified using a lower boundary of the 95% confidence interval of ROR > 1, with at least 3 cases and p-value < 0.05.
- Sensitivity analyses were conducted based on reporter qualification and continent.
Main Results:
- Out of 30,769 buprenorphine reports, 20 dental problem cases were identified with sublingual/buccal buprenorphine.
- Sublingual/buccal buprenorphine showed overreporting of dental problems compared to other buprenorphine formulations (ROR = 15.10) and methadone (ROR = 6.02).
- This overreporting trend was consistent across sensitivity analyses, with exceptions noted in Europe.
Conclusions:
- Sublingual/buccal buprenorphine may be linked to a higher risk of reported dental problems.
- These findings do not diminish the therapeutic benefits of sublingual/buccal buprenorphine in managing opioid use disorders.
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