Dapagliflozin (Farxiga) for Type 2 Diabetes Mellitus.

Because dapagliflozin has been shown to induce glycosuria, patients should be warned about the most common clinical sequelae of osmotic diuresis, hypotension, and hypoglycemia. Systolic blood pressure typically decreases by 2.3 to 5.6 mm Hg. However, hypotension is relatively uncommon (number needed to harm [NNH] = 337) and mainly affects older adults, patients on loop diuretics, and those with renal impairment. Hypoglycemia occurs infrequently overall (NNH = 133). 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). However, detection bias may be a contributor, because three patients had microscopic hematuria at baseline, and those in the intervention group may have had more frequent urinalyses because of glycosuria.4 Dapagliflozin should not be used in patients with known bladder cancer, and patients should be told to notify their physician if they experience any hematuria. 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.