Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data
Ferit Bayram, Ahmet Akici, Asli Melda Apari, Volkan Aydın
Abstract
OBJECTIVE: Local anaesthetics (LAs), almost indispensable aspect of dental practice for pain-free procedures, occasionally leads to worrisome adverse events (AEs). We aimed to compare serious and nonserious AEs of LAs for dental reasons in the US Food and Drug Administration AE Reporting System. METHODS: We retrospectively analysed dental AE reports associated with LAs in the Food and Drug Administration AE Reporting System database from its inception to April 2024. We described AEs by patients' demographic and clinical characteristics and compared ester and amide LA-associated AEs by their severity. RESULTS: We identified 1956 dental cases with a significant increase of AE reports after 2017. Lidocaine and articaine were the most commonly reported LAs (40.4% and 39.2%, respectively). Serious AEs constituted 46.2%, more commonly in females than males (56.6% vs 43.4%, P < .001) and in those on concomitant medications (70.2% vs 42.2, P < .001). These were also significantly higher in epinephrine-containing LAs (70.1%) than that without (34.2%, P < .01). Ester LAs had increased risk of serious AEs (odds ratios [OR]: 3.86; 95% confidence intervals [CI]: 2.77-5.39), particularly as hospitalization, life-threatening event, or death. The odds of serious AEs were lower with lidocaine (OR: 0.59; 95% CI: 0.48-0.71) and articaine (OR: 0.63; 95% CI: 0.52-0.76). CONCLUSION: Our study showed higher rate of serious AEs with ester LAs and those with vasoconstrictor-added practices. Besides, serious outcomes appear as more likely in females and those where additional drug use was reported. CLINICAL RELEVANCE: The integration of clinical evidence with pharmacovigilance data has the potential to influence clinicians' LA preferences in dental practice, enabling more informed and evidence-based decision-making.