In recent medical news, the type-2 diabetes medication Onglyza has been accused of causing severe injuries in patients. In particular, an advisory committee from the FDA recently announced that it agrees with the recent safety assessment of medical experts that Onglyza can cause heart failure in patients.

The drug company AstraZeneca Plc has been at the center of criticism from the FDA advisory committee for failing to provide sufficient side effect warnings regarding their drug. The advisory panel had recommended that the pharmaceutical company update Onglyza’s warning label to include heart failure. In the same announcement, the panel also addressed similar concerns regarding Takeda Pharmaceuticals’ type-2 diabetes medication, Nesina.

Onglyza Heart Failure Side Effect Investigation

Heart failure occurs when the heart cannot adequately pump blood through the heart, interrupting all biological functioning. Both Onglyza and Nesina are DPP-4 inhibitors (same family as Januvia) which work by encouraging insulin production.

The studies were analyzed by the FDA as part of a broader investigation into the safety of diabetes treatment drugs. In December 2008, the FDA ordered all relevant manufacturing companies to conduct a series of studies to prove whether or not diabetes medications, like Onglyza, increased the risk of heart disease.

While the FDA advisory panel found that neither Onglyza nor Nesina caused sudden cardiac death or stroke, the data did indicate a significant risk of heart failure. The panel stated that the statistics indicated that Onglyza carries a significant risk of heart failure, while the risk for Nesina was inconclusive.

The results of Nesina were modest in this study, but experts believe that it calls for further studies. Despite their findings, the panel did not recommended any prescription restrictions, mainly because the deaths in the study could not be definitively linked to Onglyza.

Overall, the FDA panel found the results of the study to be concerning but recommends further studies to be conducted to confirm if there actually is a link between Onglyza and heart failure.

While the panel’s conclusion does not automatically mean the FDA will agree with their assessment, but will most likely influence the agency’s future decisions.

Overview of Onglyza Complications

Onglyza (saxagliptin) was approved by the FDA in 2009 to be a type-2 diabetes treatment drug. As mentioned before, it is manufactured by AstraZeneca and has become one of the most popular treatment drug of its purpose.

In contrast to some of its family members, Onglyza does not cause the body to put on weight while controlling its blood sugar levels. This feature led the drug to garner $709 million in total profit of 2012, with analysts predicting the level to rise to $2.47 billion by 2018.

Also mentioned before, Onglyza belongs to an incretin-based therapy drug family called DPP-4 inhibitors. These medicines help the pancreas secrete more insulin and stop the liver from making excess sugar. It works by breaking down an incretin hormone called GLP-1, which is primarily responsible for signaling the pancreas to manufacture insulin.

However in type-2 diabetes patients GLP-1 levels are naturally reduced, which causes the pancreas to produce less insulin and allows for blood sugar levels to rise. Onglyza and other DPP-4 inhibitors prevent GLP-1 from being processed so quickly, which allows for the pancreas to receive the message to produce adequate amounts of insulin.

Many patients have reported finding success with drug, as it allows them to maintain a healthy lifestyle while controlling their diabetes symptoms. Unfortunately, a number of patients have reported developing heart failure and complained that the company failed to warn them of this side effect.

This concern led to the FDA releasing a safety warning in April 2015, warning patients that Onglyza could increase the chances of heart failure. The agency announced this warning after going over a recent study, which analyzed 16,000 patients; the study found that Onglyza patients faced a 27 percent greater risk of heart failure, compared to the control group.

Other complications reported from using Onglyza were: pancreatic cancer, pancreatitis, and thyroid cancer. Many of these injured patients have filed legal actions against AstraZenca, for failing to protect them against the side effects of the drug.