
FDA Adds Warning Label to Two Diabetes Drugs
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
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
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.
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