Saxagliptin (marketed as Onglyza and Combiglyze XR): FDA to Review Heart Failure Risk

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The FDA informs cardiology, endocrinology, and pharmacy personnel that the Agency is investigating a possible association between Saxagliptin and heart failure.

Onglyza, Saxagliptin, Combiglyze,

Background of Saxagliptin

Saxagliptin (marketed as Onglyza and Kombiglyze XR) is a type 2 diabetes drug that increases the amount of insulin produced by the body after meals, when blood sugar is high.

FDA Alert on Saxagliptin

A study published in the New England Journal of Medicine (NEJM) reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of Saxagliptin compared to an inactive treatment. Despite the fact that no increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received Saxagliptin were found, the manufacturer is expected to submit the trial data to FDA by early March 2014, after which FDA will conduct a thorough analysis and report findings publicly.

FDA Recommendation on Saxagliptin

“Patients should not stop taking Saxagliptin and should speak with their health care professionals about any questions or concerns. Health care professionals should continue to follow the prescribing recommendations in the drug labels.”

Contacting the FDA to report cases with Saxagliptin

In case of detection of adverse events or side effects related to the use of Saxagliptin, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

  • The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
  • The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
  • The completed form can be faxed to: 1-800-FDA-0178

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