Onglyza and Heart Failure: Still No Word from the FDA

Published on October 7, 2015 by Sandy Liebhard

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U.S. health regulators have yet to announce any label changes for Onglyza, a Type 2 diabetes medication that may be associated with an increased risk of heart failure. The U.S. Food & Drug Administration (FDA) has been reviewing the drug for over a year now, after results from a major clinical trial found that patients taking saxagliptin – the active ingredient in Onglyza – were 27% more likely to be hospitalized for heart failure compared to those taking a placebo.

Onglyza Safety Concerns

Known as SAVOR-TIMI, the trial also suggested that patients taking Onglyza faced a significantly increased-risk of all-cause mortality. The study involved 16,492 Type 2 diabetes patients with established cardiovascular disease or at high risk of cardiovascular disease. According to FDA reviewers, 798 patients died during the trial. However, SAVOR-TIMI did meet the primary safety objective, demonstrating that Onglyza did not increase the risk for cardiovascular death, nonfatal myocardial infarction and nonfatal ischemic stroke as compared to placebo.

In April, the FDA convened a panel of outside medical advisors to review data from the SAVOR-TIMI trial. The members voted 14-to-1 to recommend that new information about heart failure to be added to the labels of Onglyza and Kombiglyze XR, a combo drug that contains saxagliptin and metformin. One panel member voted to pull the drugs from the market. While the FDA is not required to follow the recommendations of its advisory panels, it does so in most cases.

Onglyza belongs to the class of Type 2 diabetes drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, and works by the pancreas to produce insulin. While the FDA has yet to announce any label changes in regards to Onglyza and heart failure, it did issue an alert last month to warn that DPP-4 inhibitors had been linked to dozens of reports of severe joint pain. Of the 33 reports received by the FDA between October 16, 2006 and December 31, 2013, five involved Onglyza. The affected patients began experiencing joint pain from 1 day to years after they started taking a DPP-4 inhibitor, and symptoms were usually relieved within a month of ceasing treatment.

Onglyza Legal Help

The attorneys at Bernstein Liebhard LLP are now offering free Onglyza lawsuit reviews to patients who may have been hospitalized for heart failure while using this Type 2 diabetes drug. To learn more, please call .

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