A popular diabetes medication has received an updated Onglyza heart failure warning from the FDA explaining potential dangers for those who take Onglyza.

Onglyza, generically known as saxagliptin, is manufactured by AstraZeneca and was approved by the U.S. Food and Drug Administration in 2009. It is used to help those with high blood sugar levels, as is the case with type-2 diabetes, to effectively control their blood sugar.

Onglyza can be a preferable drug to many patients because it does not promote weight gain as a side effect. In 2015, Onlgyza sales reached almost $800 million and sales are expected to keep rising.

The drug is an incretin mimetic, which means that this drug class works by encouraging the pancreas to secrete more insulin. This stops the liver from making too much sugar. When a certain hormone, GP-1, is released into the blood after someone eats a meal, this hormone tells the pancreas to release insulin.

A person with diabetes does not secrete enough GP-1, so the pancreas does not produce enough insulin. The result of this is that there is too much sugar in the blood. Onglyza makes sure that the pancreas secretes enough insulin so that the liver does not make too much glucose.

Onglyza has been quite successful for many people with type-2 diabetes. However, with growing reports of patients being hospitalized for heart failure, the FDA has been prompted to release an Onglyza heart failure warning.

Two particular studies, the SAVOR study and the EXAMINE study, both found an increase of heart failure among Onglyza patients.

The SAVOR study looked at about 16,500 patients who took Onglyza. Researchers found that it did not protect the heart, as they had hypothesized, but that it instead could be the cause of an 27% increased rate of hospitalization for heart failure. It also was connected with an increased risk of “all cause mortality.”

Another study that prompted the FDA Onglyza heart failure warning, the EXAMINE study, looked at over 5,000 patients. Researchers found that 3.9 percent of Onglyza patients were hospitalized for heart failure, compared to only 3.3 % who took a placebo.

The FDA Onglyza Heart Failure Warning

The FDA warns that those who take Onlgyza may be at an increased risk for heart failure. In 2014, the FDA first released an Onglyza heart failure warning. The 2014 Onlgyza heart failure warning was based on studies that reported an increased incidence of hospitalization for heart failure among patients who took drugs like Onglyza. The FDA requested more data from the drug makers to make further recommendations.

In 2016, an update to the original Onglyza heart failure warning was issued. The FDA stated that their safety review “has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”

They suggest that Onglyza patients contact their doctors if any of the following symptoms present while taking Onlgyza:

• Unusual shortness of breath during daily activities
• Trouble breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach

If you or someone you love has experienced Onglyza heart failure, you may be entitled to legal compensation.