New Warning Labels to be Issued for Some Diabetes DrugsApr 15, 2016
The U.S. Food and Drug Administration (FDA) announced new warnings to be added to the labels of some commonly prescribed drugs for type 2 diabetes. These medications contain the compounds saxagliptin and alogliptin, in either single ingredients or in combination, Newsday reports.
Following the FDA's review of two major clinical trials, the agency announced the new warnings. The findings were that patients taking drugs with saxagliptin or alogliptin were hospitalized more frequently for heart failure than patients who received placebos, according to Newsday.
The new warnings affect the following medications: Onglyza, which contains saxagliptin; Kombiglyze XR, an extended release compound containing saxagliptin, the standard diabetes drug, Metformin; Nesina, an alogliptin drug; Kazano, an alogliptin and metformin combination; and Oseni, which has alogliptin and pioglitazone.
Dr. Gerald Bernstein, an endocrinologist and a former president of the American Diabetes Association said, "The studies are worthwhile and they are bringing a risk factor to the forefront." Dr. Bernstein said that both compounds are known as dipeptidyl peptidase inhibitors, or DPP-4 drugs, are prescribed to type 2 diabetics and along with diet and exercise, help to lower blood sugar. People with type 1 diabetes are not prescribed drugs with saxagliptin and alogliptin.
Januvia, a widely prescribed type 2 diabetes drug, is also a DPP-4 inhibitor, but its chemical composition differs from saxagliptin and alogliptin, and is therefore not included in the added cautionary warning labels.
In the study that focused on saxagliptin, 3.4 percent of patients receiving medications with the drug were hospitalized for heart failure. The trial that centered on alogliptin found that 3.9 percent of patients who took that drug developed heart failure. This condition is marked by shortness of breath, difficulty breathing when lying down, and swelling of the feet, ankles and legs.
Type 2 diabetes has escalated along with the obesity epidemic in the United States. The American Diabetes Association estimates that 9.3 percent of the U.S. population, or 29.1 million people have type 2 diabetes.