Adverse event notifications implicating metformin with lactic acidosis in Australia

摘要: Abstract Objective To summarise the reported lactic acidosis cases associated with metformin from Australian Therapeutic Goods Administration (TGA) and estimate incidence of metformin-associated (MALA) in Australia. Method All “lactic acidosis” to TGA between January 1971 October 2014 were included. Data extracted included patient demographics, medical history co-existing conditions, dosage relevant pathology results. Result A total 152 suspected MALA this study. For 20 patients outcome was unknown. There 23 (n = 132, 17.4%) as deceased. Plasma lactate levels higher non-survivors (p = 0.02). Thirty-five 26.5%) have at least one pre-existing contraindication use metformin; proportion not different who died or survived. Renal impairment most common contraindication. Approximately 75% clinical condition which might cause acidosis. Metformin dosage, plasma serum creatinine correlated. Based on TGA, Australia estimated be 2.3 (95% CI, 1.5–3.1) per 100,000 patient–years 1997 2011. Conclusion Pre-existing such renal impairment, acute illnesses frequently MALA. The lower than previous studies other countries, probably due nature spontaneous reports TGA.