P201: Dental Adverse Events with Transmucosal Buprenorphine Used to Treat Opioid Use Disorder and Pain: A Case Series
Poster Presenter
Samantha Cotter
Safety Evaluator
FDA United States
Objectives
During routine surveillance, we identified a data mining signal for transmucosal buprenorphine (TMB) but not methadone or naltrexone, prompting this analysis, the purpose of which was to investigate the potential association between TMB and dental adverse events (AEs).
Method
We searched the FDA Adverse Event Reporting System (FAERS) database and medical literature from 2002 to 2018 for potential cases of interest involving TMB products. We characterized distinct cases of TMB exposure reporting dental decay, tooth loss and tooth fracture.
Results
We identified 305 cases of dental AEs reported with TMB use. The mean age of the patients in this case series was 42 years (range 18-71 years), and the median time to diagnosis was 24 months (range 0.5-182 months). Many cases reported a combination of dental decay, tooth loss, and tooth fractures in numerous teeth. Health care professionals reported many of the cases. Information in the case series provided documentation of extensive dental AEs including “all upper,” “all lower,” “all,” “majority,” “most,” “multiple teeth,” and “rampant decay.”
Of these cases, 26 involved patients with no reported prior history of dental problems. Although most of the cases were in patients using TMB products for OUD, a subset of patients (n=28) experienced severe dental AEs while receiving products indicated for pain or stated the indication was for pain.
Approximately half (n=151) of the cases reported a treatment for the events. The most common clinical outcome reported was tooth extraction. The most common dental management included surgical interventions, root canal procedures, and restorative procedures.
Conclusion
Our findings provide reasonable evidence of a causal association between TMB and severe dental AEs. Poor oral health from such AEs may result in substantial clinical or social consequences.
Although OUD itself may be associated with poor dental health (1), features of the cases in this series (e.g., rapidity of onset, good oral hygiene) suggest a contributory role for TMB. Others have hypothesized that the observed dental AEs may result from the pH-lowering effects of TMB and reduced salivary flow (2). Recently published population-level data support our case-based observations (3).
Supported by information in this case series, on January 12, 2022, FDA required manufacturers to include a Warning advising consumers and clinicians of the risk of dental AEs with TMB products. Simultaneously, FDA issued a Drug Safety Communication to increase awareness of this risk and highlight potential mitigation measures such as oral rinsing with water and waiting at least one hour after TMB use before brushing teeth.
FDA recognizes the key role TMB plays in the management of OUD. Risks we describe here should not deter use of TMB products but be used to increase awareness of the risk of dental AEs so prescribers and patients can take appropriate steps to maintain good oral health.
References:
(1). D'Amore M, et al. Oral health of substance-dependent individuals: impact of specific substances. J Subst Abuse Treat. 2011;41:179-85.
(2). Suzuki J, Park EM. Buprenorphine/naloxone and dental caries: a case report. Am J Addict. 2012;21:494-5.
(3). Etminan M, et al. Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease. JAMA. 2022;328:2269–71.
