FDA reviewers concerned over potential CV risks of Onglyza (saxagliptin) in T2D patients-AstraZeneca

According to comments from FDA reviewers, there could be safety issues with AstraZeneca's Type 2 Diabetes drug Onglyza (saxagliptin). An FDA advisory committee is due to discuss the issue next week, potentially changing the label for Onglyza as well as other DPP4 inhibitor class drugs. The reviewers concluded that though there was no statistically significant increase in the death rate during trials, data from the Phase III SAVOR trial revealed "an increased risk of hospitalization for heart failure was noted in subjects treated with saxagliptin, and FDA sensitivity analyses suggested a potential increased risk of all-cause mortality in saxagliptin-treated subjects."