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FDA Reviews Saxagliptin (Onglyza and Kombiglyze XR) For Heart Failure Risk



Washington, DC: The Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.

The request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with 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 the FDA by early March 2014, after which the FDA will conduct a thorough analysis and report findings publicly.

At this time, the FDA considers information from the NEJM study to be preliminary. 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, when blood sugar is high.



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DIABETES MEDICATION SIDE EFFECTS LEGAL ARTICLES AND INTERVIEWS

Saxagliptin Heart Failure and Death Lawsuits Filed
Saxagliptin Heart Failure and Death Lawsuits Filed Santa Clara, CA The diabetes drug saxagliptin is the subject of 14 lawsuits filed this week in New Jersey, alleging it raises the risk of heart failure. Lawyers for the plaintiffs estimate there are between 150 and 200 saxagliptin cases are pending nationwide, and may, ultimately, reach into the thousands. While most of the cases filed to date are brought by plaintiffs who have congestive heart failure or other cardiac symptoms, a handful of cases were brought on behalf of saxagliptin users who died [READ MORE]


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