Onglyza

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    Onglyza Criteria

    • Took one of the following medications for type2 diabetes
      • Onglyza (AstraZeneca brand of saxagliptin) approved July 31, 2009
      • Kombiglyze XR (AstraZeneca brand of saxagliptin + metformin) approved Nov 5, 2010
    • Was diagnosed with any of the following injuries while on the medication
      • Heart failure
      • Congestive heart failure (CHF)
      • Death due to heart failure
    • No legal representation

    Onglyza Background Information

    Generic

    saxagliptin (Onglyza); metformin and saxagliptin (Kombiglyze XR)

    Issues

    Onglyza is a type 2 diabetic drug in a class known as DPP-4 Inhibitors which are used to control blood glucose levels in type 2 diabetes patients and has been linked to Congestive Heart Failure (CHF), myocardial infarction, stroke, unstable angina & heart failure as well as severe joint pain and pancreatitis and pancreatic cancer.

    MDL 2734

    Eastern District of Kentucky, Chief U.S District Court Judge Karen K. Caldwell. (On February 2, 2018 panel granted motion to transfer. Judge Caldwell was nominated to the bench by George W. Bush in 2001. She recent ruled in favor on plaintiffs on an Essure multi-plaintiff and medical malpractice claims against the hospital to be remanded back to state court.)

    Manufacturer

    AstraZeneca

    FDA Warnings

    • February 2014 – FDA issued Safety Communication as a result of a New England Journal of Medicine study that reported patients are at an increased risk of heart attack while taking Saxagliptin.
    • April 2015 – The FDA’s Endocrinologic and Metabolic Advisory Committee voted 14-1 in favor of changing the drug’s label in light of results from a post-market study (SAVOR) that found Onglyza was associated with a 27% increase in hospitalization for heart failure, as well as a higher risk of all-cause mortality.
    • April 2016 – FDA ordered change in warning label to be updated to advise patients about the risk of heart failure after evaluating two large scale clinical trials for people with type 2 diabetes, which found that 3.5% of people taking Saxagliptin were hospitalized for heart failure.

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