Levin, Papantonio, Rafferty, Proctor, Buchanan, O'Brien, Barr & Mougey, P.A., Pensacola, FL 32502, United States.
Curr Drug Saf. 2024;19(2):261-267. doi: 10.2174/1574886318666230731151447.
Prior research has suggested buprenorphine-containing medications may be associated with an increased risk of dental disorders. However, published data describing adverse dental reactions in buprenorphine users by active ingredient composition and route of administration are limited.
The purpose of this study was to evaluate the influence of formulation on spontaneous reporting of dental disorders among patients treated with buprenorphine.
Adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) between 2015 and 2022 were analyzed. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated to measure disproportionality of dental disorder reporting as classified by 39 Medical Dictionary for Regulatory Activities preferred terms.
Compared to pooled reports for all other drugs across FAERS, both buprenorphine monotherapy (ROR 3.09; 95% CI 2.61-3.66) and combination buprenorphine/naloxone (ROR 14.61; 95% CI 13.34-16.01) were associated with positive disproportionality signals. Signals of disproportionate dental disorder reporting were also detected for buprenorphine medicines administered by sublingual (ROR 20.03; 95% CI 18.04-22.24), buccal (ROR 4.46; 95% CI 3.00-6.61) and oral (ROR 7.17; 95% CI 5.03-10.22) routes, but not for other modalities. In considering active ingredient and route together, sublingual buprenorphine monotherapies (ROR 23.55; 95% CI 17.84-31.11) and sublingual buprenorphine/naloxone (ROR 19.47; 95% CI 17.39-21.80) were each associated with disproportionate reporting of dental disorders.
Subject to the limitations of spontaneous adverse event data, this study identified significantly disproportionate reporting of dental disorders to FAERS among patients treated with buprenorphine- containing medications, including formulations administered by sublingual, buccal and oral routes. These findings are consistent with prior data and suggest that regular oral care and proper dental hygiene be emphasized for patients undergoing therapy with orally dissolving buprenorphine.
先前的研究表明，含有丁丙诺啡的药物可能与牙齿疾病的风险增加有关。然而，目前关于丁丙诺啡使用者中根据活性成分组成和给药途径描述不良反应的已发表数据有限。
本研究旨在评估制剂对丁丙诺啡治疗患者中自发报告的牙齿疾病的影响。
对 2015 年至 2022 年间向美国食品和药物管理局不良事件报告系统（FAERS）提交的不良事件报告进行了分析。使用 39 个监管活动医学词典（Medical Dictionary for Regulatory Activities，MedDRA）首选术语来计算报告比值比（Reporting Odds Ratio，ROR）和 95%置信区间（Confidence Interval，CI），以衡量牙齿疾病报告的不均衡程度。
与 FAERS 中所有其他药物的汇总报告相比，丁丙诺啡单药治疗（ROR 3.09；95%CI 2.61-3.66）和丁丙诺啡/纳洛酮联合治疗（ROR 14.61；95%CI 13.34-16.01）均与阳性不均衡信号相关。经舌下（ROR 20.03；95%CI 18.04-22.24）、颊部（ROR 4.46；95%CI 3.00-6.61）和口服（ROR 7.17；95%CI 5.03-10.22）途径给予丁丙诺啡药物也检测到牙齿疾病报告不均衡的信号，但其他途径则没有。在同时考虑活性成分和途径的情况下，舌下丁丙诺啡单药治疗（ROR 23.55；95%CI 17.84-31.11）和舌下丁丙诺啡/纳洛酮（ROR 19.47；95%CI 17.39-21.80）均与牙齿疾病的报告不均衡相关。
受自发不良事件数据的限制，本研究在接受丁丙诺啡药物治疗的患者中发现了与 FAERS 相比，牙齿疾病报告明显不均衡，包括经舌下、颊部和口服途径给予的制剂。这些发现与先前的数据一致，表明接受口腔溶解丁丙诺啡治疗的患者应强调定期口腔护理和适当的口腔卫生。
