February 11, 2014 — The U.S. Food and Drug Administration (FDA) is investigating a study linking Onglyza (saxagliptin) and Kombiglyze XR to a 27% increased risk of hospitalization for heart failure.
The study, published in the New England Journal of Medicine, did not link saxagliptin to an increased risk of heart attack, stroke, cardiovascular events, or death.
The FDA has published a Drug Safety Communication to announce that they will conduct a thorough analysis of raw data from the SAVOR clinical trial, which was conducted by AstraZeneca and Bristol Myers-Squibb. The actions are part of a broader investigation into the heart risks of diabetes drugs. The drug-makers have until early March to comply.
FDA recommendation for patients and doctors:
“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.”
Onglyza and Kombiglyze XR (saxagliptin) are type-2 diabetes drugs that help control blood-sugar levels. Saxagliptin inhibits DPP-4, an enzyme that normally breaks down insulin, which results in lower blood-sugar after a patient eats a meal.
Do I have an Onglyza Lawsuit?
The Schmidt Firm, PLLC is currently accepting Onglyza and Kombiglyze XR induced injury cases in all 50 states. If you or somebody you know has been injured by heart failure after taking Onglyza or Kombiglyze XR (saxagliptin), you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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