FDA Drug Safety Podcast: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)

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Welcome to the FDA Drug Safety Podcasts for healthcare professionals from the Division of Drug Information. On February 11, 2014, the FDA announced that it requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the drug and heart failure. This request resulted from a study published in the New England Journal of Medicine (or NEJM), which reported an increased rate of hospitalization for heart failure with the use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The manufacturer is expected to submit the trial data to FDA by early March 2014 after which we will conduct a thorough analysis and report our findings publicly.

At this time, we consider information from the NEJM study to be preliminary.  Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.

Saxagliptin is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. It works by increasing the amount of insulin produced by the body after meals. Healthcare professionals should continue following the prescribing recommendations in the drug labels and reporting side effects involving saxagliptin products to the FDA MedWatch program at www.fda.gov/medwatch

Thank you for listening. A link to the full communication and the references can be found at www.fda.gov/DrugSafetyCommunicationsIf you have drug questions, you can reach us at druginfo@fda.hhs.gov

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Page Last Updated: 12/11/2014
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