E Hascoët1, J Mahé2, H Meillard1, H Théophile3, A Cloitre1, P Lesclous4. 1. Inserm, UMR 1229, RMeS, Regenerative Medicine and Skeleton, Université de Nantes, UFR Odontologie, CHU de Nantes, Unité Fonctionnelle de Chirurgie Orale, PHU4 OTONN, ONIRIS, Nantes, France. 2. Service de Pharmacologie Clinique, CHU de Nantes, Nantes, France. 3. Pôle de Santé Publique, Service de Pharmacologie Médicale, Centre Régional de Phramacovigilance de Bordeaux, Bordeaux, France. 4. Inserm, UMR 1229, RMeS, Regenerative Medicine and Skeleton, Université de Nantes, UFR Odontologie, CHU de Nantes, Unité Fonctionnelle de Chirurgie Orale, PHU4 OTONN, ONIRIS, Nantes, France. philippe.lesclous@univ-nantes.fr.
Abstract
OBJECTIVES: The primary aims of the present study were (1) to quantify and characterize anaphylactic type I reactions related to local anesthetics (LAs) drawing on the French Pharmacovigilance Database System over a 35-year period and (2) to focuse on reactions associated with dental procedures. The secondary aim was to infer an incidence rate in dental practice. MATERIALS AND METHODS: All cases of anaphylactic reactions were selected using the algorithmic Standardized MeDRA Query "anaphylactic reaction." For each reaction, comprehensive data were collected, in particular the severity of symptoms, risk factors for anaphylaxis, and allergy testing. Imputability was assessed and a crude incidence rate in dental practice was estimated. RESULTS: The first-line search identified 416 anaphylactic reactions, mostly of grade II (138) or III (240) severity. When restricted to dental practice, this number fell to 26 (grade I: 4; grade II: 10; grade III: 11; and grade IV: 1). Lidocaine was most often involved (81.49%) and mostly associated with anaphylactic reactions of grade II and III. Overall, 11 cases of fatal anaphylaxis were recorded, but no in dental practice. In dental practice, lidocaine was also the most frequently involved LA (57.69%). CONCLUSIONS: All these findings highlight the very low incidence of type I-IgE-mediated reactions to LA, particularly in dental practice. The incidence rate of LA anaphylctic episodes in dental practice was estimated as 0.0261 anaphylactic episodes per million LA cartridges. CLINICAL RELEVANCE: True anaphylactic reactions to LAs do occur and may justify a thorough investigation in dental practice.
OBJECTIVES: The primary aims of the present study were (1) to quantify and characterize anaphylactic type I reactions related to local anesthetics (LAs) drawing on the French Pharmacovigilance Database System over a 35-year period and (2) to focuse on reactions associated with dental procedures. The secondary aim was to infer an incidence rate in dental practice. MATERIALS AND METHODS: All cases of anaphylactic reactions were selected using the algorithmic Standardized MeDRA Query "anaphylactic reaction." For each reaction, comprehensive data were collected, in particular the severity of symptoms, risk factors for anaphylaxis, and allergy testing. Imputability was assessed and a crude incidence rate in dental practice was estimated. RESULTS: The first-line search identified 416 anaphylactic reactions, mostly of grade II (138) or III (240) severity. When restricted to dental practice, this number fell to 26 (grade I: 4; grade II: 10; grade III: 11; and grade IV: 1). Lidocaine was most often involved (81.49%) and mostly associated with anaphylactic reactions of grade II and III. Overall, 11 cases of fatal anaphylaxis were recorded, but no in dental practice. In dental practice, lidocaine was also the most frequently involved LA (57.69%). CONCLUSIONS: All these findings highlight the very low incidence of type I-IgE-mediated reactions to LA, particularly in dental practice. The incidence rate of LA anaphylctic episodes in dental practice was estimated as 0.0261 anaphylactic episodes per million LA cartridges. CLINICAL RELEVANCE: True anaphylactic reactions to LAs do occur and may justify a thorough investigation in dental practice.