Rx for Type 2 Diabetes Gets Thumbs-Up from FDA

FDA approves Jardiance along with diet and exercise to treat Type 2 diabetes

(RxWiki News) A healthy diet and regular exercise are key elements of diabetes treatment. But some patients need medications to go along with that diet and exercise. The US Food and Drug Administration (FDA) has just approved one such medication.

The FDA announced that it has approved Jardiance (empagliflozin) tablets as an add-on to diet and exercise to improve blood sugar control in adults with Type 2 diabetes.

"Ask your pharmacist about emerging treatments for Type 2 diabetes."

Type 2 diabetes is a condition marked by high blood sugar levels. Those high blood sugar levels can lead to serious complications, including heart disease, kidney damage, nerve damage, blindness and amputation. About 26 million people in the United States have Type 2 diabetes.

In an FDA press release, Curtis J. Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said "Jardiance provides an additional treatment option for the care of patients with type 2 diabetes. It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes."

Jardiance is part of a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors. These medications lower blood sugar levels by keeping the kidney from reabsorbing blood sugar. Then the body excretes more blood sugar, which lowers blood sugar levels.

The FDA approval of Jardiance came after seven clinical trials including 4,480 Type 2 diabetes patients who received the medication. Those trials showed that patients taking Jardiance had improved HbA1c levels (a measure of blood sugar over time) compared to those who received a placebo (fake medication).

According to the FDA, Jardiance has been studied as a stand-alone treatment and in combination with other treatments for Type 2 diabetes, including metformin, sulfonylureas, pioglitazone (brand name Actos) and insulin.

The FDA cautioned that Jardiance should not be used to treat Type 1 diabetes, in those with diabetic ketoacidosis (increased ketones in blood or urine), or in those with kidney disease or on dialysis.

As with any medication, Jardiance may cause some side effects, the most common of which are urinary tract infections and female genital infections.

Jardiance can also cause dehydration. In turn, dehydration can cause a drop in blood pressure, leading to possible dizziness or fainting and reduced kidney function.

Boehringer Ingelheim Pharmaceuticals, Inc., distributes Jardiance.

Review Date: 
August 1, 2014