The U.S. Food and Drug Administration (FDA) has made plans to assemble an advisory panel to review the side effect risks of type-2 diabetes medication Onglyza after a recent report suggested the drug could lead to heart failure.

The Endocrinologic and Metabolic Drugs Advisory Committee will meet to analyze the heart risks linked to the diabetes medication Onglyza (generic saxagliptin) as well as Kombioglyza XR, which combines Onglyza with metformin.

The FDA requested that drug manufacturers AstraZeneca and Bristol-Myers Squibb submit their clinical trial data so they could accurately assess the diabetes medication for heart side effects. The advisory committee will look at the recent Onglyza heart study along with the clinical data results from the drug manufacturers in order to determine if any further steps are needed to protect consumers.

Onglyza Heart Risks Study

Onglyza was approved to treat type-2 diabetes by the FDA in 2009. Due to its ability to increase insulin produced in the body while not adding extra weight onto the patient, it quickly became a widely prescribed treatment.

Drug analysts predict Onglyza will have a total profit of $2.47 billion by 2018. However, despite its popularity a recent study found that the medication may also carry a deadly side effect — heart failure.

An Onglyza heart study published in the New England Journal of Medicine followed 16,492 type-2 diabetes patients. Researchers found that patients taking Onglyza had a 27 percent higher risk of heart failure compared to those taking other diabetes medications.

The FDA issued a safety warning in April 2015 warning Onglyza patients of the risk of heart failure. Heart failure symptoms include:

• Swelling of the abdomen or legs
• Rapid weight gain
• Edema (fluid retention)
• Fatigue
• Dyspnea (difficulty breathing or painful breathing)

Other Onglyza Complications

In addition to heart failure, Onglyza has also been linked to other serious complications including pancreatic and thyroid cancer.

In 2013, researchers studied the autopsies of 20 diabetes patients including eight who took an incretin mimetic like Onglyza. According to their findings, patients who used an incretin mimetic drug had a pancreas that was 40 percent larger than normal. They also found pre-cancerous cell growth and small tumors in the pancreas as well.

Another study the same year performed by Johns Hopkins University researchers found that diabetic patients hospitalized with pancreatitis were twice as likely to be taking an incretin mimetic drug like Onglyza.

In addition to pancreatic complications, numerous studies also link incretin mimetic drugs to a greater risk for thyroid cancer. The FDA issued a safety warning in 2011 about the increased risk of thyroid cancer while taking Onglyza.

A study performed by UCLA researchers found that the incretin mimetic drug Byetta carries a five-times greater risk of patients developing thyroid cancer compared to other diabetes medication.

Onglyza Lawsuits

As more research surfaces showing the life-threatening side effects of Onglyza, many patients are choosing to file a Onglyza lawsuit against manufacturers for allegedly failing to warn about these risks.