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.