Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data
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. Met...
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| Language: | English |
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Elsevier
2025-06-01
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| Series: | International Dental Journal |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S0020653925000735 |
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| author | Ferit Bayram Ahmet Akici Asli Melda Apari Volkan Aydin |
| author_facet | Ferit Bayram Ahmet Akici Asli Melda Apari Volkan Aydin |
| author_sort | Ferit Bayram |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-c8d7b8d4ded8461eabbe30a08f35eda7 |
| institution | OA Journals |
| issn | 0020-6539 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Dental Journal |
| spelling | doaj-art-c8d7b8d4ded8461eabbe30a08f35eda72025-08-20T01:49:08ZengElsevierInternational Dental Journal0020-65392025-06-017531705171210.1016/j.identj.2025.03.002Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System DataFerit Bayram0Ahmet Akici1Asli Melda Apari2Volkan Aydin3Department of Oral and Maxillofacial Surgery, School of Dentistry, Marmara University, Istanbul, Turkiye; Corresponding authors: Department of Oral and Maxillofacial Surgery, School of Dentistry, Marmara University; Department of Basic Sciences - Pharmacology, School of Dentistry, Marmara University, Basibuyuk Yolu 9/3, 34854 Maltepe Istanbul, Turkiye.Department of Medical Pharmacology, School of Medicine, Marmara University, Istanbul, TurkiyeDepartment of Medical Pharmacology, School of Medicine, Marmara University, Istanbul, TurkiyeDepartment of Basic Sciences - Pharmacology, School of Dentistry, Marmara University, Istanbul, Turkiye; Corresponding authors: Department of Oral and Maxillofacial Surgery, School of Dentistry, Marmara University; Department of Basic Sciences - Pharmacology, School of Dentistry, Marmara University, Basibuyuk Yolu 9/3, 34854 Maltepe Istanbul, Turkiye.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.http://www.sciencedirect.com/science/article/pii/S0020653925000735Adverse eventsLocal anaestheticsAmidesEstersSerious |
| spellingShingle | Ferit Bayram Ahmet Akici Asli Melda Apari Volkan Aydin Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data International Dental Journal Adverse events Local anaesthetics Amides Esters Serious |
| title | Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data |
| title_full | Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data |
| title_fullStr | Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data |
| title_full_unstemmed | Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data |
| title_short | Analysis of Adverse Events Associated With Dental Local Anaesthetics Using Food and Drug Administration Adverse Event Reporting System Data |
| title_sort | analysis of adverse events associated with dental local anaesthetics using food and drug administration adverse event reporting system data |
| topic | Adverse events Local anaesthetics Amides Esters Serious |
| url | http://www.sciencedirect.com/science/article/pii/S0020653925000735 |
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