FDA Approves Dapagliflozin for Type 2 Diabetes — Physician’s First Watch
FDA Approves Dapagliflozin for Type 2 Diabetes
By Amy Orciari Herman
Dapagliflozin (Farxiga) — an inhibitor of sodium-glucose co-transporter 2 — has been approved as an adjunct to diet and exercise in adults with type 2 diabetes, the FDA announced on Wednesday. The drug blocks the reabsorption of glucose by the kidney, thus decreasing blood glucose levels.
The approval comes with a series of caveats:
Dapagliflozin should not be used in patients on dialysis or those with moderate-to-severe renal impairment, end-stage renal disease, diabetic ketoacidosis, or type 1 diabetes.
It should not be used in those with active bladder cancer, as more bladder cancers were diagnosed in dapagliflozin users during clinical trials.
Dehydration may occur, which could lead to hypotension, dizziness, and declines in renal function.
The FDA is mandating six post-marketing studies to evaluate cardiovascular risk, bladder cancer risk, and safety and efficacy in children, among other outcomes.