FDA Adds Warning Label to Two Diabetes Drugs

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FDA added warning labels to medications containing saxagliptin and alogliptin after clinical trials linked the drugs to increased risk of hospitalization for heart failure.

On April 5, 2016, FDA said that it would be adding new warnings and precautions to the labels of Type 2 diabetes medicines containing saxagliptin and alogliptin. An FDA safety review determined saxagliptin and alogliptin might increase the risk of heart failure, particularly in patients with heart or kidney disease.

Saxagliptin and alogliptin are part of a class of dipeptidyl peptidates-4 (DPP-4) inhibitor drugs, which are used to lower blood sugar in adults with Type 2 diabetes. FDA cited the following medications as containing saxagliptin and alogliptin: Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin extended release), Nesina (alogliptin), Kazano (alogliptin and metformin), and Oseni (alogliptin and pioglitazone).

In February 2014, FDA said it was planning to review the heart failure risk associated with saxagliptin after a study published in the New England Journal of Medicine (NEJM) observed a “higher incidence of hospitalization for heart failure among patients treated with saxagliptin.” In 2014, FDA said it considered the findings to be preliminary but found the risk serious enough to continue investigation. In April 2015, FDA held an Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the results of the trial and determine if both drugs had a significant effect on the risk of heart failure.


FDA said it evaluated “two large clinical trials” both of which “showed that more patients who received saxagliptin- or alogliptin- containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment.” FDA references the information from these clinical trials as the reasoning for adding the Warnings and Precautions label to diabetes medications containing both DPP-4 inhibitors. In a trial with saxagliptin, 3.5% of patients who received the drug were hospitalized for heart failure, compared with 2.8% of patients receiving the placebo treatment. In the alogliptin trial, 3.9% of patients were hospitalized for heart failure, compared with 3.3% of those taking the placebo.

Source: FDA