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FDA EXAMINES HEART FAILURE RISK WITH DIABETES DRUG

FDA EXAMINES HEART FAILURE RISK WITH DIABETES DRUG

The FDA has recently issued a safety communication regarding a possible link between saxagliptin and heart failure. Saxagliptin, marketed as Onglyza and Kombiglyze XR by Bristol-Myers Squibb, is a drug used to treat type 2 diabetes. The safety communication was prompted by a study published in the New England Journal of Medicine which found use of saxagliptin was associated with increased rate of hospitalization for heart failure.

The FDA has requested clinical trial information from the manufacturer of saxagliptin which is pending. The safety communication further notes that FDA's "analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk."

Sources:

FDA,

http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm

http://www.fda.gov/downloads/Drugs/DrugSafety/UCM385315.pdf

New England Journal of Medicine,

http://www.nejm.org/doi/full/10.1056/NEJMoa1307684

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