Asparaginase‐related diabetic ketoacidosis: Analysis of the FDA Adverse Event Reporting System ( FAERS ) data and literature review

Abstract

What is Known and Objective: Diabetic ketoacidosis (DKA) may occur during asparaginase use. However, limited by the study population, the association between asparaginase and DKA has not been elucidated. The purpose of this study was to determine the potential association between asparaginase and DKA and analyse related clinical characteristics and possible risk factor.Methods: Disproportionality analysis with the reporting odd ratio (ROR) was used to detect the adverse reaction signals of asparaginase-associated DKA in Food and Drug Administration Adverse Event Reporting System (FAERS). A literature review was conducted to further analyse clinical characteristics, possible risk factor and something noteworthy in asparaginaseassociated DKA.Results and Discussion: A total of 12 reports of DKA associated with L-asparaginase (L-asp) and 6 reports associated with pegaspargase (PEG-asp) were extracted in FAERS, more than 50% of the cases were classified as serious adverse events. DKA was a positive signal of L-asp (ROR = 2.397, 95% CI 1.360-4.226), while not closely related to the use of PEG-asp (ROR = 1.602, 95% CI 0.719-3.570). Searched in PubMed, Embase and Web of Science, a total of eight patients were collected. The patients were mainly adolescent patients, aged between 11 and 25 years old with a median age of 16 years. Drug dosage form distribution is unbalanced, 7 patients received L-asp and only 1 received PEG-asp.What is New and Conclusions: The ROR of KDA caused by L-asp was statistically significant, but there was not a statistical association for DKA caused by PEG-asp.Asparaginase dosage form may affect the occurrence of DKA, but further research is needed.

Contrastive analysis on the safety of brand and generic nebivolol: a real-world pharmacovigilance study based on the FDA adverse event reporting system

“…The FAERS database has publicly opened more than 10 million AE reports received by the FDA since 2004 and is updated quarterly. In this study, we used OpenVigil 2.1 ( http://h2876314.stratoserver.net:8080/OV2/search/ ), an open tool for data mining and analysis of pharmacovigilance data using cleaned FAERS adverse event reports, to retrieve and extract the structured data of nebivolol in the FAERS database from the first quarter of 2004 to the fourth quarter of 2022 ( Li et al, 2022 ).…”