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FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin

[ 4-5-2016 ] A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to meet the body's needs. As a result, we are adding new warnings to the drug labels about this safety issue.

Saxagliptin and alogliptin are part of the class of dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, which are used with diet and exercise to lower blood sugar in adults with type 2 diabetes. Untreated, type 2 diabetes can lead to serious health problems, including blindness, nerve and kidney damage, and heart disease (see List of saxagliptin- and alogliptin-containing Medicines).

Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:

Patients should not stop taking their medicine without first talking to their health care professionals.

Health care professionals should consider discontinuing the medicine in patients who develop heart failure and monitor their diabetes control. If a patient's blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.

List of saxagliptin- and alogliptin-containing Medicines

Brand name Active ingredient(s)
Onglyza saxagliptin
Kombiglyze XR saxagliptin and metformin extended release
Nesina alogliptin
Kazano alogliptin and metformin

We evaluated two large clinical trials conducted in patients with heart disease. These clinical trials were also discussed at the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. Each trial showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo (see Data Summary). In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This is the same as 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients.

As a result, we have added new Warnings and Precautions to the labels of medicines that contain saxagliptin or alogliptin to inform of the potential increased risk of heart failure.

We urge health care professionals and patients to report side effects involving saxagliptin, alogliptin, or other medicines to the FDA MedWatch program

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