Onglyza (saxagliptin), developed by AstraZeneca, was found to cause an increased risk of heart failure.
AstraZeneca Plc's diabetes drug Onglyza (saxagliptin) may be associated with an increased rate of death, according to a preliminary review of data by the FDA.
The FDA's report, posted on the agency's website on Friday, comes ahead of an April 14 meeting of an FDA advisory panel to discuss the drug's safety. A company-sponsored trial of more than 16,000 patients known as SAVOR previously showed patients taking Onglyza had an increased risk of hospitalizations due to heart failure.
The agency's analysis found the heart failure risk valid. It also identified a possible increased risk of death from all causes.
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