Association of anti-diabetic medications with DILI: A Disproportionality analysis

Javed Faiza and Kumar Anoop

Department of Pharmacology and Clinical Research, Delhi Pharmaceutical Sciences and Research University Pushp Vihar, Sec-III, MB Road, New Delhi, INDIA


Various classes of drugs are being used in the management of diabetes mellitus. These drugs are associated with various ADRs;however, association of anti-diabetic medications are not known for drug induced liver injury (DILI). Thus, we have tried to identify an association of anti-diabetic medications with DILI. The individual case safety reports (ICSRs) were extracted from FAERS data base from January 1, 2004, (2004Q1) to December 31, 2021 (2021Q3). The reporting odds ratio (ROR), Proportional Reporting Ratios (PRRs) with associated Chi-square value was calculated with 95% confidence interval. The majority of anti-diabetic drug induced liver injury cases were found in the 18–64 years and ≥ 65 years age groups. The number of cases in male and females were almost similar. The disproportionality analysis (PRR, ROR, reports count) results have shown a significant association of drug induced liver injury with antidiabetic medications. A total of 9120 cases of drug induced liver injury were reported out of which 726 are associated with antidiabetic drugs. The subgroup analysis results have also shown significant association. The sensitivity analysis has shown decrease in the strength of signal however, association was found positive. In conclusion, we have identified a novel signal of DILI associated with antidiabetic medications.   

Article ID: O0401019 (Suppl 1)   RA  Preprint
Received: 08/06/2022 
Accepted: 08/07/2022
Published: 08/08/2022