New drug approved, meters recalled

Dapaglifozin (Farxiga), a new medication to treat type 2 diabetes, was recently approved by the FDA for use along with diet and exercise.

The drug is a sodium-glucose co-transporter 2 inhibitor. Safety and effectiveness were evaluated in 16 clinical trials of more than 9,400 patients, which showed improvement in HbA1c. It has been studied as a stand-alone therapy and in combination with other therapies, including metformin, pioglitazone, glimepiride, sitagliptin, and insulin. It should not be used to treat type 1 diabetes or patients with diabetic ketoacidosis, moderate or severe renal impairment, or end-stage renal disease. The most common side effects are genital mycotic infections and urinary tract infections. An increased number of bladder cancers were diagnosed in patients on the drug, so it is not recommended for patients with active bladder cancer. It can cause dehydration, leading to hypotension that can result in dizziness and/or fainting and a decline in renal function.

The FDA also announced a recall of some TRUEbalance and TRUEtrack blood glucose meters by Nipro Diagnostics, Inc. because they may have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dL.