Dapagliflozin (Farxiga) for Type 2 Diabetes Mellitus

Among patients also taking insulin, the risk of mild or moderate hypoglycemia increases (NNH = 20), but not the rate of major hypoglycemic episodes, defined as those requiring external assistance.2 This class of medication has also been linked to ketosis and diabetic ketoacidosis without the associated usual high levels of blood glucose.3 During phase 2 and 3 clinical trials,4,5 an imbalance was noted in the number of cases of bladder cancer (207 vs. 53 cases per 100,000 person-years in the intervention and control groups, respectively). No human studies have included pregnant or breastfeeding mothers.6 This medication is U.S. Food and Drug Administration pregnancy class C and should be avoided in the late second and third trimesters during fetal renal development. Women taking dapagliflozin are more likely to develop vulvovaginal candidiasis (6.9% to 8.5%; NNH = 15 to 19) and men are more likely to develop balanitis (2.7% to 2.8%; NNH = 40 to 42) compared with patients taking placebo.7 There is a higher risk of urinary tract infections as well (NNH = 50).8 Use of dapagliflozin will increase total cholesterol by an average of 2.5% and low-density lipoprotein cholesterol by 2.9%, which may affect the need for statin therapy.