The type-2 diabetes treatment drug, Onglyza, has been alleged to be causing numerous severe side effects in patients, including  heart failure.

According to a preliminary review of clinical trial data by the Food and Drug Administration, Onglyza could cause fatal injuries in patients. This FDA report was published on the agency’s website before a scheduled FDA advisory panel meeting in April, so the results could be discussed.

Manufactured by AstraZeneca, Onglyza was approved by the FDA in 2009 to be a treatment option for patients with type-2 diabetes. It soon became a blockbuster drug, grossing $820 million in sales in 2014 alone, but it soon came under fire for potentially fatal side effects like pancreatitis, pancreatic cancer, and heart failure.

Onglyza is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is designed to help patients maintain a healthy lifestyle by helping control blood sugar, without encouraging weight gain. These drugs work by signaling the pancreas to produce more insulin and to stop the liver from making excess sugar.

At the time Onglyza and other DPP-4 drugs were released, the medical community considered them to be miracle drugs and one of the greatest medical innovations since the discovery of insulin.

DPP-4 is an enzyme that naturally occurs in the body, which breaks down an incretin hormone called GLP-1. This hormone is responsible for signaling the pancreas to produce insulin. Insulin is vital to patients with type-2 diabetes, as it prevents fluctuations of blood sugar and allows for a healthy level of glucose.

Overview of Onglyza Heart Failure Complications

Unfortunately, problems had started for these drugs even before Onglyza was released. In 2008, the FDA had asked the manufacturers of type-2 diabetes medications to provide evidence that their drugs did not increase the risk of heart failure or any other cardiac complications.

Additionally, the agency encouraged the companies to conduct thorough investigations of this possibility, focusing on the product’s development stage.

According to the FDA Onglyza report, the clinical trial known as SAVOR, had examined more than 16,000 patients who had been prescribed Onglyza.

This study was conducted to analyze the side effects of Onglyza, with the focus on heart failure. The study showed that Onglyza users faced a 27 percent risk of heart failure, compared to patients who were prescribed a placebo.

Shortly after the SAVOR clinical trial was conducted, another Onglyza heart failure study had been published in October 2013 issue of the New England Journal of Medicine.

In 2014, the FDA announced that it would analyze the clinical trial results as part of the agency’s evaluation of any cardiac complications associated with type-2 diabetes.

The FDA has recently completed its evaluation of the SAVOR trial results, with the agency indicating that the risk of Onglyza heart failure being a valid concern.

The SAVOR study was initially conducted to see if Onglyza could provide additional health benefits to patients through cardiac relief. The researchers found no such benefits and, instead, an increased risk for heart failure.

Despite how serious this complication is, AzstraZenca and other type-2 diabetes medication manufacturers have failed to mention it on their product’s label.

This has caused numerous patients to filed injury reports to the FDA, and consider possible Onglyza lawsuits against the company for failing to protect them against the dangerous side effects of their products.