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FDAnews Drug Daily Bulletin

Type 2 Diabetes Drugs Linked to Heart Problems

April 12, 2016

Following a safety review, the FDA has decided to add warnings to the labels of Type 2 diabetes drugs containing saxagliptin and alogliptin due to the increased risk of heart failure in patients with kidney or heart disease.

The new warnings and precautions added to the labels of the dipeptidyl peptidase-4 inhibitors provide prescribing and monitoring recommendations, the agency says in a safety alert.

The alert comes after the agency evaluated two clinical trials, in which more patients treated with saxagliptin- or alogliptin-containing medications were hospitalized for heart failure versus the placebo group.