The cardiovascular safety of saxaglipti, the widely-used type 2 diabetes drug from AstraZeneca PLC, is to be reviewed following data linking the medication to cases of heart failure.
On Wednesday, the U.S. Food and Drug Administration (FDA) said it had asked for clinical trial data from AstraZeneca to investigate examine possible heart risks associated with the medicine.
The request follows a study published in September in the New England Journal of Medicine, which showed a small rise in hospital admissions for heart failure among diabetic patients prescribed saxagliptin.
According to the FDA, the study, which was supported by the drug’s developers AstraZeneca and Bristol-Myers Squibb, did not find an increase in the rate of deaths or other major cardiovascular events, including heart attack or stroke.
The FDA said it expected the clinical data to be submitted by early March, after which it will conduct a thorough analysis and publicly report its findings.
The health regulator added that information in the NEJM study is considered as preliminary and therefore patients using saxagliptin should not stop taking it, nor should healthcare professionals stop prescribing the drug.
Marketed on its own as Onglyza and in combination with an oral hyperglycemic as Kombilgyze XR, saxagliptin works by increasing the amount of natural insulin produced after eating to help control post-meal blood glucose levels in adult patients with type 2 diabetes.

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