FDA Adds Warning to Labels for Saxagliptin, Alogliptin

The warnings on labels will come after FDA reviewed long-term safety data.

FDA has announced it will add a warning to the labels for saxagliptin and alogliptin, as well as combination therapies containing these therapies, after evaluating 2 large clinical trials in patients with heart disease.

The safety review, which is now a standard part of FDA’s process for new type 2 diabetes and obesity medications, found that saxagliptin and alogliptin “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The required safety warnings will address this issue.

FDA’s action, announced late Tuesday, followed an earlier communication on February 11, 2014, as well as a discussion by the agency’s Endocrinologic and Metabolic Drugs Advisory Committee in April 2015.

In the saxagliptin trial, 3.5% of patients who received the study drug were hospitalized for heart failure compared with 2.8% who took placebo. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of patients taking the study drug were hospitalized for heart failure compared with 3.3% who took placebo.

FDA recommends that providers consider discontinuing these medications for patients who develop heart failure and monitor their diabetes. Other diabetes therapies may be required.

Symptoms that healthcare professionals should watch for in these patients include:

· Unusual shortness of breath

· Difficulty breathing when lying down

· Weakness or fatigue

· Weight gain with swelling in ankles, feet, legs, or stomach

Medications covered by this warning are:

· Onglyza (saxagliptin)

· Kombiglyze XR (saxagliptin and metformin, extended release)

· Nesina (alogliptin)

· Kazano (alogliptin and metformin)

· Oseni (alogliptin and pioglitazone)