Laure Thomas1, Christine Le Beller2, Thierry Trenque3, Joëlle Michot4, Marie Zenut5, Emmanuel Letavernier6,7,8, Nicolas Mongardon9,10,11, Dominique Vodovar12,13,14. 1. Centre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris (AH-HP), Hôpitaux Universitaires Henri Mondor, Créteil, France. 2. Centre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris (AH-HP), Hôpital Européen Georges Pompidou, F-75014, Paris, France. 3. Centre Régional de Pharmacovigilance et de Pharmacoépidémiologie, Centre Hospitalier Universitaire, Reims, France. 4. Centre Régional de Pharmacovigilance, Assistance Publique-Hôpitaux de Paris (AH-HP), Centre Hospitalier Universitaire Saint-Antoine, Paris, France. 5. Centre Régional de Pharmacovigilance, Centre Hospitalier Universitaire, Clermont-Ferrand, France. 6. Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche_S1155, Rare and Common Kidney Diseases, Matrix Remodeling and Tissue Repair, Paris, France. 7. Sorbonne Universités, Université Pierre et Marie Curie, Université Paris 6, Paris, France. 8. Explorations fonctionnelles multidisciplinaires, Hôpital Tenon, Assistance Publique - Hôpitaux de Paris (AH-HP), Paris, France. 9. Service d'anesthésie-réanimation chirurgicale, DMU CARE, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, Créteil, France. 10. Université Paris Est Créteil, Faculté de Santé, Créteil, France. 11. U955-IMRB, Equipe 03 "Stratégies pharmacologiques et thérapeutiques expérimentales des insuffisances cardiaques et coronaires", Inserm, UPEC, Ecole Nationale Vétérinaire d'Alfort, Maisons-Alfort, France. 12. Centre Anti-Poison et de Toxicovigilance de Paris - Fédération de toxicologie, Assistance Publique des Hôpitaux de Paris, Hôpital Fernand-Widal, Paris, France. 13. UFR de médecine, Université Paris-Diderot, Paris, France. 14. UMRS 1144, Inserm, Faculté de Pharmacie, Paris, France.
Abstract
AIMS: Amoxicillin (AMX)-induced crystal nephropathy (AICN) is a rarely reported adverse drug reaction (ADR) but its increase has been recently reported in the Paris area. Our aim was to investigate the incidence, characteristics and outcome of AICN in France. METHODS: Retrospective analysis of all AICN cases reported to the French National Pharmacovigilance Database and the Marketing Authorization Holders Pharmacovigilance Database. AICN notification rate was compared to intravenous AMX and AMX-clavulanate sales. RESULTS: In total, 101 AICN cases were included. Intravenous AMX/AMX-clavulanate was prescribed as surgical prophylaxis (32 surgical patients) or to treat infection (69 medical patients). AKI KDIGO stage 3 was observed in 70 patients and 24/70 patients required renal replacement therapy and/or intensive care unit admission. The annual notification rate of AICN was increased by a factor of 13 since 2010 (6 [0;7] and 77 [24;111] cases per 100 000 patient-years of exposure, before and after 2010 respectively; P < .001). In surgical patients, the increase in AICN has been reported since 2010 and was mainly related to inadequate AMX administration. In medical patients, the increase in AICN was observed since 2014. After 2014, medical patients were older (67 [42;77] vs 74 years [64;84] respectively; P < .05) and were treated more frequently for endocarditis (0/20 vs 15/49 respectively; P < .01). A contributing factor was observed or suspected in 62 patients. CONCLUSION: AICN is a severe ADR that dramatically increased in France since 2010. Assessment of AICN contributing factors and AMX drug monitoring in patients receiving high dose of AMX could reduce the risk of AICN.
AIMS: Amoxicillin (AMX)-induced crystal nephropathy (AICN) is a rarely reported adverse drug reaction (ADR) but its increase has been recently reported in the Paris area. Our aim was to investigate the incidence, characteristics and outcome of AICN in France. METHODS: Retrospective analysis of all AICN cases reported to the French National Pharmacovigilance Database and the Marketing Authorization Holders Pharmacovigilance Database. AICN notification rate was compared to intravenous AMX and AMX-clavulanate sales. RESULTS: In total, 101 AICN cases were included. Intravenous AMX/AMX-clavulanate was prescribed as surgical prophylaxis (32 surgical patients) or to treat infection (69 medical patients). AKI KDIGO stage 3 was observed in 70 patients and 24/70 patients required renal replacement therapy and/or intensive care unit admission. The annual notification rate of AICN was increased by a factor of 13 since 2010 (6 [0;7] and 77 [24;111] cases per 100 000 patient-years of exposure, before and after 2010 respectively; P < .001). In surgical patients, the increase in AICN has been reported since 2010 and was mainly related to inadequate AMX administration. In medical patients, the increase in AICN was observed since 2014. After 2014, medical patients were older (67 [42;77] vs 74 years [64;84] respectively; P < .05) and were treated more frequently for endocarditis (0/20 vs 15/49 respectively; P < .01). A contributing factor was observed or suspected in 62 patients. CONCLUSION: AICN is a severe ADR that dramatically increased in France since 2010. Assessment of AICN contributing factors and AMX drug monitoring in patients receiving high dose of AMX could reduce the risk of AICN.
Authors: Elisabeth Toulouse; Christophe Masseguin; Brigitte Lafont; Gordon McGurk; Anna Harbonn; Jason A Roberts; Sophie Granier; Arnaud Dupeyron; Jean Etienne Bazin Journal: Anaesth Crit Care Pain Med Date: 2018-10-25 Impact factor: 4.132
Authors: C A Naranjo; U Busto; E M Sellers; P Sandor; I Ruiz; E A Roberts; E Janecek; C Domecq; D J Greenblatt Journal: Clin Pharmacol Ther Date: 1981-08 Impact factor: 6.875