The U.S. Food and Drug Administration (FDA) has launched an investigation into the safety of an AstraZeneca PLC diabetes drug after a recent study found that users of the medication were more likely to suffer heart failure than a control group. The agency requested last month that AstraZeneca supply it with clinical trial data in order to examine a possible link between the drugmaker’s saxagliptin and heart failure. For your information, saxagliptin is marketed as Onglyza and Kombiglyze XR.
The request by the FDA stems from a study that appeared in the New England Journal of Medicine in September, which found that saxagliptin users were hospitalized at a higher rate for heart failure than users of a control treatment. According to the FDA, it will conduct a “thorough analysis” of the trial data after it receives the information from AstraZeneca. The agency cautioned that it viewed the study as preliminary, saying patients should not stop taking the drug and that doctors should continue prescribing it as recommended on its label.
The study, according to the FDA, didn’t find that saxagliptin users were more likely to die or suffer a heart attack or stroke than the control group. The FDA said that its analysis of the saxagliptin clinical trial data was part “of a broader evaluation of all Type 2 diabetes drug therapies and cardiovascular risk.”
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