An FDA advisory committee recommends adding a warning to the label for the diabetes medication Onglyza, alerting patients to a possible risk of hospitalization for heart failure.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met in April to consider the results of clinical studies that revealed that patients who took Onglyza were more likely to be hospitalized for heart failure.

The panel voted to recommend the FDA add information to Onglyza’s label describing the results of clinical studies on the drug’s cardiovascular side effects.

The committee examined the results of the SAVOR clinical trial, published in The New England Journal of Medicine in 2013. This trial followed over 16,000 patients with type-2 diabetes for over two years, documenting cardiovascular events that occurred over that period. Some patients were given saxagliptin (the generic name for Onglyza), and others received a placebo.

While the researchers did not find any increase in ischemic events, they did note that patients on saxagliptin were hospitalized for heart failure more often than those who took the placebo.

In response to that study, the FDA in February 2014 requested additional clinical trial data from AstraZeneca, the maker of Onglyza. Other data also showed that Onglyza patients had a higher mortality rate than those who took a placebo. But since the data did not suggest any particular reason for that finding, the committee took no particular action in response.

Clinical evidence showed a 27 percent greater likelihood of hospitalization for heart failure for patients taking Onglyza. The committee determined this increase was acceptable since it did not exceed the 30-percent threshold used in the trials to determine acceptability of risk.

The FDA is not bound by the committee’s recommendation but will take it into consideration in future review of Onglyza’s labeling.

In a statement published on AstraZeneca’s website, the company said it would continue to investigate the SAVOR study’s findings of increased hospitalization for heart failure associated with Onglyza.

What is Onglyza?

Onglyza is manufacturer AstraZeneca’s brand name for the drug saxagliptin. AstraZeneca’s Kombiglyze XR also includes saxagliptin, in combination with the older diabetes medication metformin.

Saxagliptin is one of a class of diabetes medications known as DPP-4 inhibitors. These drugs reduce high blood sugar levels by mimicking the effects of incretin hormones, which stimulate the pancreas to release insulin after eating meals.

Higher levels of insulin help move sugar from the blood and into the rest of the body’s tissues. DPP-4 inhibitors also reduce the levels of sugar produced by the liver.

Onglyza has been FDA-approved since 2009 for the treatment of type-2 diabetes. Sales of Onglyza in 2014 generated $820 million in revenue for AstraZeneca.

The FDA has required special analysis of the cardiovascular effects of diabetes medications since 2008. Patients with type 2 diabetes already have two to four times the risk of heart disease than persons without diabetes.

According to the FDA’s guidance, manufacturers of diabetes medications are encouraged to provide evidence that the drugs will not increase the risk of adverse cardiovascular events. The guidance also provides more robust standards for clinical trials used to determine FDA approval.