April 15, 2015 -- The diabetes drugs Onglyza and Kombiglyze should carry a new warning that they may increase the risk of heart failure and death, a U.S. Food and Drug Administration advisory panel says.
In a 14-1 vote Tuesday, the panel said the drugs' prescribing labeling should warn that they can increase the risk of hospitalization for heart failure and the risk of death from all causes, the Associated Press reported.
The panel also decided -- in a 13-1 vote with one abstention -- that the drugs had an acceptable heart safety profile.
In Tuesday's meeting, the panel reviewed data from a 16,000-patient study that examined the heart safety of the two diabetes drugs, the AP reported. The FDA typically follows the advice of its advisory panels.