Quoted from http://www.reuters.com/article/2015/04/10/astrazeneca-onglyza-fda-idUSL2N0X70PU20150410
AstraZeneca's diabetes drug Onglyza may increase death rate - FDA
By Toni Clarke
April 10 (Reuters) - AstraZeneca Plc's diabetes drug Onglyza may be associated with an increased rate of death, according to a preliminary review of data by the U.S. Food and Drug Administration.
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 safety of Onglyza and a similar drug from Takeda Pharmaceutical Co called Nesina. Onglyza won U.S. approval in 2009 and Nesina in 2013.
A trial of more than 16,000 patients known as SAVOR previously showed patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalization due to heart failure.
The agency's analysis found the heart failure risk to be valid, and also identified a possible increased risk of death from all causes.
The overall trial results did not reveal a higher death risk, but a more detailed analysis examining only patients who took the drug suggests "a significantly increased risk of all-cause mortality," the review found.