One of the most commonly prescribed type-2 diabetes treatments Onglyza should carry a new warning label that includes the increased risk of heart failure, according to an FDA advisory committee recommendation.

The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to add the heart failure risk to Onglyza after a SAVOR study published in the New England Journal of Medicine showed the diabetes medication increased the risk of hospitalization due to heart failure by 27 percent.

After reviewing the SAVOR study, the FDA conducted their own thorough analysis and found that the risk of heart failure as a side effect of Onglyza was valid. Although the FDA is not required by the Advisory Committee’s recommendation, they typically take their findings into consideration before making a final decision.

Onglyza Overview

Onglyza (saxagliptin) was released on the U.S. market after its FDA approval in 2009. Onglyza is part of a class of drugs known as incretin mimetics which work by increasing the incretin hormones to stimulate the release insulin without causing weight gain.

Due to its ability to control blood sugar without weight gain, Onglyza quickly became one of the most commonly prescribed type-2 diabetes medications. According to British Medical Journal editor Deborah Cohen, when the new DPP-4 drugs appeared on the market, they were considered “the biggest breakthrough since the discovery of insulin nearly a hundred years before.”

However, in the time since their release drugs like Onglyza have fallen under scrutiny over the safety and side effects of the type-2 diabetes medication.

Onglyza Heart Study

The New England Journal of Medicine published a study after analyzing 16,492 type-2 diabetes patients who were given either Onglyza or a placebo. Researchers discovered that Onglyza patients had a 27 percent increased risk of heart failure compared to those on a placebo. 

Onglyza heart failure symptoms include:

• Rapid or irregular heartbeat
• Getting tired easily
• Shortness of breath
• Swelling in legs, ankles and feet
• Weakness
• Inability to exercise
• Sudden weight gain
• Increased nighttime urination

Onglyza Complications

In addition to heart failure, another study published in the American Diabetes Association Journal Diabetes, found a link between Onglyza and pancreatic cancer. Researchers studied the autopsies of diabetes patients including those who took an incretin mimetic like Onglyza.

Those patients taking an incretin mimetic had a pancreas that was 40 percent larger than normal. Researchers also found that Onglyza patients also had pre-cancerous cell growth and small tumors in the pancreas as well.

Onglyza Lawsuits

Patients filing incretin mimetic drug lawsuits claim that Onglyza side effects were more serious than manufacturers described. There has been at least one Onglyza heart failure lawsuit filed so far by a daughter who is suing AstraZeneca for $50,000 after her mother allegedly suffered heart failure due to taking Onglyza.

If you suffered from serious Onglyza side effects you may be able to file a lawsuit in order to financially recover from medical bills as well as other damages. Contact an Onglyza lawyer to find out if you have legal claim.