Study Prompts FDA to Take Another Look at Saxagliptin

FDA grants Fast Track status to oliceridine
FDA grants Fast Track status to oliceridine

The FDA has requested clinical trial data from Bristol-Meyers Squibb and AstraZeneca for their medications Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin, metformin HCl extended-release) due to a possible link between the use of these drugs and heart failure. The request is based on a research study published in the New England Journal of Medicine (NEJM) in October 2013. Both medications are used in the treatment of type 2 diabetes.

The NEJM study of 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events received either saxagliptin or placebo and were examined for a median of 2.1 years. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Saxagliptin did not increase or decrease the rate of ischemic events, but more patients in the saxagliptin group were hospitalized for heart failure compared to the placebo group (3.5% vs. 2.8%; hazard ratio 1.27; 95% CI 1.07–1.51; P=0.007).

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The FDA considers the data from the NEJM study to be preliminary, and will be using this clinical trial data as part of its broader evaluation of type 2 diabetes drugs in terms of cardiovascular risk. Patients are warned to not stop taking saxagliptin and to speak with their health care professionals with any questions or concerns. Health care professionals are advised to continue to adhere to the prescribing recommendations in the drug labels.

For more information call (888) 463-6332 or visit the FDA Safety Alert Page.