FDA Issues New Warning Labels for Some Diabetes Drugs

Type 2 diabetes is escalating in proportion to the obesity epidemic in the United States with the American Diabetes Association estimating that 9.3 percent of the U.S. population, or 29.1 million people, have the disease. The U.S. Food and Drug Administration (FDA) announced the warnings following two major clinical trials. They found that patients taking saxagliptin or alogliptin were more frequently hospitalized for heart failure than patients who received placebos, Newsday reports.

Heart failure, also known as congestive heart failure, causes shortness of breath, difficulty breathing when lying down and swelling of the ankles, feet, and legs. This debilitating heart condition is most likely to occur in patients who already have other cardiac problems and kidney disease, according to drug regulators.

Medications that will receive the additional warning labels are: Onglyza, which contains saxagliptin; Kombiglyze XR, an extended release compound containing saxagliptin and the standard diabetes drug, Metformin; Nesina, an alogliptin drug; Kazano, an alogliptin and metformin combination; and Oseni, which contains alogliptin and pioglitazone.

Both saxagliptin and alogliptin are technically known as dipeptidyl peptidase inhibitors, or DPP-4 drugs, and are prescribed to type 2 diabetics to help lower blood sugar. With type 2 diabetes, the body does not properly use insulin. The pancreas over time, is not able to keep up with the need to produce enough of the hormone to control blood sugar.

Dr. Gerald Bernstein, an endocrinologist and former president of the American Diabetes Association said, “The studies are worthwhile and they are bringing a risk factor to the forefront.”