Kombiglyze XR Heart Failure

Kombiglyze heart failure settlements
The U.S. Food & Drug Administration (FDA) is now investigating a possible link between Kombiglyze XR and heart failure. The review follows release of a clinical trial which suggested saxagliptin was associated with a 27% increased risk of hospitalization for this potentially life-threatening condition.

Filing a Kombiglyze XR Lawsuit Can Help

You may be eligible to file a Kombiglyze XR lawsuit if you or someone you care about were hospitalized with a heart failure diagnosis while using this medication to treat Type 2 diabetes. To learn if you are eligible to pursue compensation from the manufacturers of Kombiglyze XR, please call (888) 994-5118 to discuss your case with one of our legal experts.

What is Kombiglyze XR?

Kombiglyze XR is a DPP4-inhibitor that belongs to a class of Type 2 diabetes treatments called incretin mimetics. The medication consists of both saxagliptin and metformin. Kombiglyze XR is marketed by AstraZeneca, which obtained FDA approval for the drug in November 2010. AstraZeneca also markets Onglyza, a saxagliptin-only diabetes medication that was approved the previous year.

Kombiglyze XR and Heart Failure

  • April 2016:  The FDA announced that a recent large clinical trial found that 3.5 percent of patients receiving saxagliptin were hospitalized for heart failure, compared with 2.8 percent of patients receiving a placebo. As a result, the label for Kombiglyze XR would be updated to include new information regarding a potential risk of heart failure.  Read More
  • April 2015: An FDA advisory panel overwhelmingly recommended that information regarding a potential increased risk of heart failure be added to the labels of saxagliptin-containing medications, including Kombiglyze XR. While the FDA is not required to follow the recommendations of its advisory panels, it usually does so.
  • February 2014: The FDA announced a safety review of saxagliptin and an increased risk of heart failure. The agency acted after a large clinical trial suggested that patients taking saxagliptin were 27% more likely to be hospitalized as a result of this complication. The trial, entitled SAVOR-TIMI53, involved 16,500 patients who were randomly assigned a placebo or saxagliptin. After about two years, 2.8% of placebo patients were hospitalized with heart failure, compared to 3.5% of patients on saxagliptin.

What is Heart Failure?

A patient experiences heart failure when the heart is no longer able to efficiently pump oxygenated blood to other parts of the body. As the condition progresses, the muscles of the heart can become thicker, forcing it to pump faster. The heart will grow weaker, and the patient will develop congestive heart failure as fluid builds up in the lungs, liver, gastrointestinal tract, and the arms and legs. There is no cure for heart failure, but there are a number of effective treatments that can relieve symptoms and prolong life.

Heart failure symptoms may include:

  • Cough
  • Fatigue, weakness, faintness
  • Loss of appetite
  • Frequent urination at night
  • Rapid or irregular pulse, or palpitations (a sensation of feeling the heart beat)
  • Shortness of breath when you are active or after you lie down
  • Swollen liver or abdomen
  • Swollen feet and ankles
  • Inability to sleep due to shortness of breath
  • Weight gain

Were You Hospitalized with Heart Failure While Taking Kombiglyze XR? Contact an Attorney Today.

The nationwide law firm of Bernstein Liebhard LLP is now offering free, no-obligation legal reviews to individuals who were hospitalized with heart failure diagnosis while using Kombiglyze XR. To learn more, please contact our office by calling (888) 994-5118.

  1. FDA (2014) “FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)” http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm
  2. Reuters (2015) “FDA panel backs safety updates for AstraZeneca, Takeda drugs” http://www.reuters.com/article/2015/04/14/us-astrazeneca-onglyza-fda-idUSKBN0N51U920150414
  3. Medline Plus (2015) “Heart Failure Overview” https://www.nlm.nih.gov/medlineplus/ency/article/000158.htm
Last Modified: April 7, 2016

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