Amoxicillin‐induced crystal nephropathy: A nationwide French pharmacovigilance databases study

Thomas, Laure; Beller, Christine Le; Trenque, Thierry; Michot, Joëlle; Zénut, M.; Letavernier, Emmanuel; Vodovar, Dominique

doi:10.1111/bcp.14328

Cited by 14 publications

(33 citation statements)

References 29 publications

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“…The main results of this study is the observation of a 4.5% AICN incidence over a 3 years period in patients receiving high IV doses of AMX, and that AICN represented the cause of AKI in more than one third of KDIGO stage 2–3 AKI in this population. Thus, as compared to previous reports [ 1 , 13 ], these results suggest that AMX nephrotoxicity may be underestimated. Interestingly, only female gender appeared as a risk factor of AICN, while AMX dose (even if indexed to weight) and modalities of AMX administration (continuous vs. discontinuous infusion) were not significantly associated with AICN.…”

Section: Discussionsupporting

confidence: 52%

“…In comparison, in the study of Vodovar et al, among the 45 patients diagnosed with AICN, a crystal search was performed in 20% of patients [ 1 ], and detected in 68/180 AICN patients (38%) in the ANSM nationwide study [ 14 ]. In order to limit AKI misclassification in our study, medical files of patients with AKI stage 2–3 were analyzed by 2 practitioners, including by a specialist in pharmacovigilance, and classified according to Vodovar AICN criteria, which were used in past studies [ 1 , 13 ].…”

Section: Discussionmentioning

confidence: 99%

“…Medical records were reviewed by a nephrologist (JFA) and a specialist in pharmacovigilance (GD) in a blinded fashion. AICN diagnosis was retained in accordance with diagnosis criteria proposed by Vodovar et al [ 1 , 13 ]. Vodovar criteria include inclusion and exclusion criteria.…”

Section: Methodsmentioning

confidence: 99%

“…Interestingly, most cases occurred after 2010, while only one case was declared before 2010. Even though the methodology of this study was prone to declaration bias, it suggests that recent factors (i.e., changes in drug administration, modification of industrial process…) may account for the increasing incidence of AICN [ 1 , 13 ]. The higher incidence of AICN was also underlined in another French study that analyzed AKI in patients exposed to high dose AMX for the treatment of osteoarticular infections [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

“…Although this inquiry does not allow to definitively confirm risk factors of AICN, it led to the following recommendations: limitation of AMX daily dose to 12 g, limitation of each administration to a maximum of 2 g to be infused in at least 20 min, favoring diuresis using IV hydration, and monitoring of renal function under treatment. In a recent report, most of these cases were reported in the English literature, showing older age and endocarditis as risks factors for AICN in medical patients [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

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High Incidence of Amoxicillin-Induced Crystal Nephropathy in Patients Receiving High Dose of Intravenous Amoxicillin

Garnier

Dellamaggiore

Brilland

et al. 2020

JCM

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Background: Amoxicillin (AMX)-induced crystal nephropathy (AICN) is considered as a rare complication of high dose intravenous (IV) AMX administration. However, recently, its incidence seems to be increasing based on French pharmacovigilance centers. Occurrence of AICN has been observed mainly with IV administration of AMX and mostly under doses over 8 g/day. Given that pharmacovigilance data are based on declaration, the real incidence of AICN may be underestimated. Thus, the primary objective of the present study was to determine the incidence of AICN in the current practice. Materials and Methods: We conducted a retrospective study between 1 January 2015 and 31 December 2017 in Angers University Hospital. Inclusion criteria were age over 18 years-old and IV AMX administration of at least 8 g/day for more than 24 h. Patients admitted directly into the intensive care units were excluded. Medical records of patients that developed Kidney Disease:Improving Global Outcome (KDIGO) stage 2–3 acute kidney injury (AKI) were reviewed by a nephrologist and a specialist in pharmacovigilance. AICN was retained if temporality analysis was conclusive, after exclusion of other causes of AKI, in absence of other nephrotoxic drug administration. Results: A total of 1303 patients received IV AMX for at least 24 h. Among them, 358 (27.5%) were exposed to AMX doses of at least 8 g/day and were included. Patients were predominantly males (68.2%) with a mean age of 69.1 years-old. AMX was administered for a medical reason in 78.5% of cases. Patients received a median dose of AMX of 12 g/day (152.0 mg/kg/day). Seventy-three patients (20.4%) developed AKI, 42 (56.8%) of which were KDIGO stage 2 or 3. Among the latter, AICN diagnosis was retained in 16 (38.1%) patients, representing an incidence of 4.47% of total patients exposed to high IV AMX doses. Only female gender was associated with an increased risk of AICN. AMX dose was not significantly associated with AICN development. Conclusion: This study suggests a high incidence of AICN in patients receiving high IV AMX doses, representing one third of AKI causes in our study. Female gender appeared as the sole risk factor for AICN in this study.

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Section: Discussionsupporting

confidence: 52%