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Some diabetes drugs to get new warning labels, FDA says

Diabetes drugs containing either of two key compounds can cause heart failure in certain patients, federal drug regulators said Tuesday as they announced new warnings to be added to the labels of nearly a half dozen commonly prescribed medications.

All drugs targeted in the alert are for people with type 2 diabetes and contain the compounds saxagliptin and alogliptin, either as single ingredients or in combination. Heart failure is most likely to occur in patients who have existing cardiac problems and kidney disease, drug regulators said Tuesday.

Medications affected by the new warning include: 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 has alogliptin and pioglitazone.

The warnings were announced by the U.S. Food and Drug Administration following the agency’s review of two major clinical trials. Both investigations found that patients taking drugs with saxagliptin or alogliptin were more frequently hospitalized for heart failure than patients who received placebos.

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

Bernstein said both compounds are technically known as dipeptidyl peptidase inhibitors, or DPP-4 drugs, which are prescribed to type 2 diabetics because along with diet and exercise, the compounds help lower blood sugar. Drugs containing saxagliptin and alogliptin are not prescribed to people who have type 1 diabetes.

The widely prescribed type 2 diabetes drug, Januvia, also a DPP-4 inhibitor, was not included among those that will receive new cautionary warnings on their labels because its chemical composition differs from saxagliptin and alogliptin.

All of the inhibitors work by increasing the amount of insulin produced by the body after meals when blood sugar is elevated, said Bernstein, an endocrinologist and coordinator at the Friedman Diabetes Program, a division of Northwell Lenox Hill Hospital in Manhattan.

In one of the studies reviewed by the FDA that focused on saxagliptin, 3.5 percent of patients receiving medications with the drug were hospitalized for heart failure. The second trial, which centered on alogliptin, found that 3.9 percent of patients who took that drug developed the debilitating heart condition.

Heart failure, also known as congestive heart failure, is marked by shortness of breath; difficulty breathing when lying down, and swelling of the ankles, feet and legs.

Type 2 diabetes is a growing global public health concern and in the United States alone the number of people affected has escalated in sync with the obesity epidemic.

Officials with the American Diabetes Association say that with type 2 diabetes the body does not properly use insulin, a condition called insulin resistance. The pancreas initially produces extra insulin but, over time it isn’t able to keep up and can’t make enough of the hormone to control blood sugar. The association estimates that 9.3 percent of the U.S. population, or 29.1 million people have type 2 diabetes.

The exact cause of type 1 diabetes remains unknown. However, there are potent hints that it may have autoimmune underpinnings, which means the body’s own warrior cells and proteins from the immune system may play a role in the decimation of the glandular organ’s insulin-producing beta cells.

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