Sodium-glucose co-transporter type 2 inhibitors (SGLT2i), or gliflozins, have been approved in Europe since 2020 for treating type 2 diabetes, heart failure (HF), and chronic kidney disease (CKD). These conditions, especially prevalent in older adults, justify the increasing use of SGLT2i in this population. Diabetes affects up to 24.4 % of individuals aged 75–79 [1], HF prevalence rises sharply with age [2], and kidney failure, also age-related, impacted 700 million people globally in 2017 [3]. Reflecting this trend, SGLT2i prescriptions in France rose by 583 % between 2021 and 2023, with a 677 % increase in those aged 60 and over [4].

Despite proven efficacy, SGLT2i carry risks of adverse drug reactions (ADRs), notably urinary or genital infections and euglycemic diabetic ketoacidosis (euDKA). These agents promote glycosuria and insulin-independent glucose lowering, potentially triggering ketogenesis through insulin deficiency and increased glucagon secretion [5]. Clinical trials have reported low diabetic ketoacidosis (DKA) incidence (0.1–0.76 per 1,000 patient-years [6]), but often underrepresent older adults or exclude those with multiple comorbidities. A recent meta-analysis even found a higher DKA risk in older patients [7].

Given limited real-world data in the elderly, this study examines reported cases of DKA linked to SGLT2i use in patients over 65 using the French Pharmacovigilance Database (FPVD).