Signal Detection of Blood Glucose Lowering Drugs and Herbal Medicines in the Thai Databases on Adverse Drug Events (Thai Vigibase)

Abstract

Objective: To identify drug-adverse event (AE) pairs with potential signals for risks from 10 blood glucose lowering drugs, dipeptidyl peptidase 4 inhibitors, and herbal medicines. Methods: This research was a retrospective analytical study using data of AE reports in the Thai Vigibase starting at the year with first report of each drug available to 2017. The study’s disproportionality reporting of case and non case were analyzed and presented as reporting odds ratio (ROR) and the lower limits of the 95% confidence interval (CI). The criteria to determine the potential signal were at least three reports of AEs involving the interested drugs, ROR with the lower limits of 95% CI more than 1 and being critical AEs by WHO definition. Results: Total number of AE reports of blood glucose lowering drugs and herbal medicines were 517,099 reports and 2,267 reports respectively. Drug-AE pairs with potential signal were sitagliptin-rhabdomyolysis (ROR=30.75, 95%CI 9.75,96.96), Centella asiatica-polyuria (ROR=11.91, 95%CI 4.67,30.37), Andrographis paniculata-anaphylactic shock (ROR=5.26, 95%CI 2.97,9.33), Derris scandens Benth-polyuria (ROR=4.49, 95%CI 1.55,13.02), A. paniculata-anaphylaxis (ROR=4.21, 95%CI 2.33,7.60), Cissus quadrangularis-polyuria (ROR=3.78, 95%CI 1.07,9.33) and A. paniculata-angioedema (ROR=2.70, 95%CI 1.83,3.97). Rhabdomyolysis from sitagliptin was documented in the Micromedex. Polyuria was adverse effect of C. asiatica and D. scandens Benth noted in the National List of Essential Medicines: Herbal Medications. There were no evidence on such AEs from A. paniculata and C. quadrangularis. Conclusions: The study identified potential signals from 7 drug-AE pairs with one pair involving blood glucose lowering agent, and six involving herbal medicines. Three pairs were known ADRs, namely sitagliptin-rhabdomyolysis, C. asiatica-polyuria and D. scandens Benth-polyuira. Four pairs were unknown ADRs, namely anaphylactic shock, anaphylaxis and angioedema of A. paniculata and C. quadrangularis -polyuria. Risk communication of these potential signals should be conducted to healthcare professionals to careful use of these drugs.