An FDA advisory panel has recommended that the popular type-2 diabetes medication Onglyza (saxagliptin) have its warning label updated to include the risk of heart failure.

The recommendation comes on the heels of recent studies and analyses indicating that Onglyza patients may experience heart complications at a greater rate than patients taking a placebo.

Onglyza belongs to a family of drugs called dipeptidyl peptidase-4 (DDP-4) inhibitors, also called incretin mimetics. These drugs help control blood sugar levels by signaling the pancreas to increase insulin production. DDP-4 inhibitors are popular with type-2 diabetes patients.

The FDA approved Onglyza in 2009 as a treatment for type-2 diabetes. Since it’s release, Onglyza has become one of the most popular diabetes treatments in America, grossing billions for it’s manufacturers, Bristol-Myers Squibb and AstraZeneca.

Even while riding a wave of success, Onglyza has been accused of causing patients to suffer from major complications, such as heart failure and pancreatic cancer.

Overview of Onglyza Heart Failure Concern

After hearing reports of complications, the FDA called together expert panelists from the Endocrinologic and Metabolic Drugs Advisory Committee. The advisory committee evaluated Onglyza research and looked at the drug’s safety risks.

The panel explored the results of a 2013 study known as the SAVOR study, and a follow-up study known as the EXAMINE study. The studies indicated that Onglyza patients had an increased risk of hospitalization for heart failure, and seemed to also indicate an increased risk of mortality.

Taking into account all of the available information, the FDA panel recommended that manufacturers Bristol-Myers and AstraZeneca update the warnings on Onglyza’s label to include an increased risk of heart failure.

AstraZeneca stated on its webpage that it would continue to investigate the risk of heart failure from Onglyza.