The recent Onglyza FDA warning urged manufacturers AstraZeneca and Bristol-Myers to include the risk of heart failure on the medication’s warning label.

The Onglyza FDA warning was released in April 2015, with the agency’s advisory committee urging the agency to require the manufacturers to add heart failure as a possible side effect.

The recent Onglyza FDA warning came after an agency panel voted to require AstraZeneca to include warnings for heart failure on the medication’s warning label. This was to alert the medical community and patient population of the potential side effects associated with the diabetes drug.

The Onglyza FDA warning label came after the agency reviewed data from the SAVOR study published in the 2013 issue of New England Journal of Medicine, consisting of 16,000 subjects and 1,222 reports of cardiac complications.

According to the SAVOR results, AstraZeneca had received a number of alleged Onglyza cardiovascular reports below the threshold number that would trigger the FDA to withdraw Onglyza from the market.

To reach this point, the occurrence rate of alleged Onglyza cardiovascular events would have to be 30%. Even though the SAVOR study had only found a 27% rate of occurance, the FDA requested further investigating into this alleged correlation.

The concern regarding Onglyza heart failure has been prevalent since a 2013 study indicating that similar medications could increase the risks of other serious side effects like pancreatic cancer.

An earlier Onglyza FDA warning was released in February 2014 which warned patients and doctors about the potential link between the diabetes drug and heart failure.

Overview of Onglyza Treatment and Complications

Onglyza (saxagliptin) is a popular type-2 diabetes medication, which is a part of a relatively new family of type-2 diabetes treatment drugs. Onglyza quickly gained popularity among type-2 diabetes patients because it does not cause weight gain.

Approved by the FDA in 2009, Onglyza is a part of the incretin mimetics medication class and is often prescribed to patients having trouble controlling blood pressure. Incretin mimetics work by imitating the body’s natural incretin hormones and ultimately helps the body produce sufficient insulin levels and decreases sugars made in the liver.

Insulin is a vital component of the body’s metabolic process, as it allows the body to retrieve sugar and other nutritional properties from food. Without sufficient insulin levels, the body may be forced to metabolize fat instead of sugar.

This causes the blood to become too acidic which can lead to a possible diabetic attack. Onglyza and other type-2 diabetes medications are meant to prevent patients from experiencing dangerous diabetic complications.

However, recent injury reports of Onglyza heart failure has spurred major concern in the medical community. Heart failure occurs when the heart muscle becomes too weak to pump sufficient blood throughout the body, which can result in cardiac failure. Patients with certain blood pressure conditions or who are taking certain medications may be at higher risk for heart failure.

Even though the SAVOR study showed no statistical correlation between Onglyza and heart failure, it raised concern for medical experts calling for further investigation. At this time, scientists are not sure why Onglyza may be causing heart failure.

However, AstraZeneca and Bristol-Myers Squibb have the civil responsibility of warning patients against all potential side effects of their product, including possible Onglyza heart failure.