Drug-induced insulin autoimmune syndrome: a clinico-epidemiological analysis integrating pharmacovigilance data and case series
Abstract
Background: Insulin autoimmune syndrome (IAS) is a rare immune-mediated hypoglycemic disorder predominantly triggered by pharmacological agents. Despite the established links to thiol-containing drugs, emerging non-thiol triggers and significant geographical reporting biases limit comprehensive risk profiling. This study integrated pharmacovigilance data and published evidence to establish the first systematic epidemiological and pharmacological profile of drug-induced IAS.
Methods: We analysed 228 IAS cases from the FDA AE Reporting System (FAERS; 2004-Q2 2024) and a systematic review of 263 published cases (1980-2024). Multimodal disproportionality analysis-including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN)-identified drug-induced adverse event signals. Associations were stratified into a three-tier evidence framework (Levels 1-3) based on methodological concordance, case counts, and strength of the supporting literature.
Results: Fifty-eight agents showed potential IAS associations, including 12 novel pharmacovigilance signals (e.g., bevacizumab, sitagliptin, amlodipine, and olmesartan). Thiol-containing drugs exhibit the strongest signals (PRR > 200; e.g., captopril, methimazole, and clopidogrel). Level 1 evidence (highest confidence) implicated the use of clopidogrel, captopril, omeprazole, and methimazole. IAS was predominantly affected in older…
How strong is the evidence?
Evidence Hub reads this as a case series, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.
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