Diabetes Drug Onglyza Increases Risk of Death: FDA

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April 10, 2015 -- The diabetes drug Onglyza increases the risk of death from all causes, according to a U.S. Food and Drug Administration report released Friday.

FDA staff analyzed the findings of a clinical trial on the heart effects of AstraZeneca's drug for type 2 diabetes and found that it was associated with "significant or near-significant" increased risk of death from all causes, not just heart problems, Bloomberg News reported.

The cause of the increased risk of death was not included in the FDA analysis.

The agency also said that patients who took Onglyza also have a 27 percent increased risk of hospitalization for heart failure compared to those who took a placebo.

Onglyza belongs to a class of diabetes drugs called DPP-4 inhibitors. FDA staff also analyzed another DPP-inhibitor called Nesina, made by Takeda Pharmaceuticals, but found no increased risk of death, Bloomberg reported.

The FDA report on the two drugs was release in advance of an April 14 meeting of an outside panel of advisers who will discuss the heart effects of the drugs.

Merck's Januvia is the same type of drug and is also being studied, but the company has not yet released the results of its heart risk trial, Bloomberg reported.

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