Onglyza heart failure risk has become a widespread concern for the patient population and medical community after the FDA released an official warning in 2014.

The Onglyza heart failure risk warning was released after the FDA received injury reports indicating patients needed hospitalization for heart failure, as well as several studies indicating the correlation between Onglyza and heart failure. At the time, the FDA requested more data from pharmaceutical companies to further investigate the risk.

The FDA Onglyza heart failure risk warning was updated in 2016, with the agency stating their safety review “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.”

The FDA further recommended that Onglyza (saxagliptin) patients seek medical attention immediately if the present any of the following symptoms:

• Shortness of breath occurring from low impact or daily activities
• Breathing difficulties while laying down
• Weakness or fatigue
• Weight gain
• Swelling in the legs, feet, ankles or stomach

Overview of Onglyza Heart Failure Risk

Onglyza is a fairly new type-2 diabetes medication that only entered the United States in 2009. It is often prescribed to help patients control blood sugar levels.

Onglyza is part of the incretin mimetic drug family which works by signaling the pancreas to produce more insulin. This also prevents the liver from producing too much sugar, allowing for proper insulin and blood sugar balance. Insulin is the hormone that allows the body to metabolize sugar instead of fat, which prevents deadly conditions like ketoacidosis and kidney failure.

Type-2 diabetes patients are also at risk for symptoms like lower limb amputation and ulcer formation, due to the lack of metabolic function. Type-2 diabetes is a chronic disease that affects millions in the United States making drugs like Onglyza vital for patients.

However, the Onglyza heart failure risk has caused many physicians to pause before prescribing the medication, especially after reviewing the studies that prompted the FDA warnings. The FDA Onglyza heart failure risk warning was spurred from the SAVOR and EXAMINE studies, both of which found an increased risk of heart failure in Onglyza patients.

The SAVOR study analyzed 16,500 Onglyza patients to look at the effects the drug may have on the body. Researchers found that Onglyza patients experienced a 27 percent increased risk of needing hospitalization for heart failure, as well as an increased of overall mortality.

The EXAMINE study analyzed 5,000 patients. One patient group was prescribed Ognlyza and the other was prescribed a placebo. Approximately 3.9 percent of patients of the Onglyza group were hospitalized for heart failure, while only 3.3 percent of patients from the placebo group were hospitalized.

At the time the FDA reviewed the results of these studies, the agency found that the Onglyza heart failure risk was not statistically significant but did call for further investigation.

In April 2015, an FDA advisory committee urged the agency to require manufacturers AstraZeneca and Bristol-Myers Squibb to update the drug’s warning label to include the Onglyza heart failure risk.

Class action investigators are currently evaluating claims alleging Onglyza heart failure, and whether or not the companies took proper measures in disclosing potential drug side effects.