February 11, 2014 — The type-2 diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR have been linked to a 27% increased risk of hospitalization for heart failure, according to a study published in the New England Journal of Medicine.
The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication to announce they will investigate the heart risks of Onglyza.
The FDA has requested full data from the SAVOR clinical trial from Bristol-Myers Squibb and AstraZeneca. The drug-makers have until March 2014 to submit trial data. The FDA will conduct a thorough analysis and report findings publicly.
The actions are part of a broader evaluation of all type-2 diabetes drugs and heart risks. The study did not find any increased risk of heart attack, stroke, cardiovascular events, or death.
“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 belong to a new class of type-2 diabetes drugs called DPP-4 inhibitors. These drugs work by inhibiting an enzyme that breaks down insulin. Saxagliptin helps control blood-sugar levels by increasing insulin production after meals.
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