FDA Panel Recommends Diabetes Drugs Highlight Heart Failure Risk

April 15, 2015
Ryan Marotta, Assistant Editor

An FDA advisory panel recommends adding a warning about the potential risk for heart failure to the labels of saxagliptin (Onglyza), saxagliptin/metformin (Kombiglyze), and alogliptin (Nesina).

An FDA advisory panel recommends adding a warning about the potential risk for heart failure to the labels of 2 of AstraZeneca’s diabetes treatments, saxagliptin (Onglyza) and saxagliptin/metformin (Kombiglyze), as well as Takeda's diabetes drug, alogliptin (Nesina).

Still, the regulatory panelists said the 3 dipeptidyl peptidase-4 inhibitors have acceptable heart safety profiles.

The panel’s decisions were partially based on the findings of a heart study involving approximately 16,000 patients that did not demonstrate an increased risk of heart attack with Onglyza compared with placebo. However, data from an AstraZeneca trial suggested the use of the drug was associated with a higher rate of heart failure.

Additionally, a preliminary FDA review determined Onglyza was associated with an increased risk of all-cause death. While the panelists were concerned by these findings, they could not identify a common cause of death.

A separate FDA review of Nesina found the drug was associated with an increase in hospitalizations for heart failure compared with placebo, though the difference was not deemed statistically significant.