The FDA issued a warning that the diabetes medication Onglyza could lead to heart failure and requested the drug manufacturer submit all clinical trial data so an accurate assessment of Onglyza could be performed.

The FDA first made this request after a study was published in the New England Journal of Medicine which found that use of Onglyza (saxagliptin) increased “hospitalization for heart failure.” It was noted that this study did not find Onglyza side effects posed an imminent risk of death. The FDA is examining the submitted evidence, according to the timeline presented in the Onglyza heart failure announcement.

The FDA Onglyza heart failure warning also noted, “at this time, we consider information from the NEJM study to be preliminary. Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.”

The FDA requested that medical professionals report any Onglyza side effects (including heart failure) to the FDA MedWatch program.

Following the FDA announcement, an advisory committee suggested that drug manufacturers AstraZeneca and Bristol-Myers Squibb include risks about Onglyza heart failure on the drug label.

About Onglyza

Onglyza is one of many type-2 diabetes medications under investigation for causing serious side effects, including heart failure. This particular medication was approved in 2009 to treat diabetes by increasing the amount of insulin produced in the body.

It is part of the class of drugs called incretin mimetics, which affect insulin production in the pancreas. Incretin mimetics are relatively new to the market, but already, the drug Avandia has been recalled due to the number of deaths caused by heart failure related to use of the drug.

In addition to Onglyza heart failure, the drug has been said to cause pancreatic cancer, thyroid cancer, and other side effects.

Onglyza Heart Failure Study

The Onglyza study published in NEJM looked at 16,492 patients who had type-2 diabetes. The researchers found that those who took Onglyza when compared to other diabetes medications had a higher rate of heart failure. Heart failure is when the heart becomes too weak to pump blood throughout the body.

The researchers thought that while the increase in Onglyza side effects was not great, it would be important to those who were already looking into diabetes medication side effects.

As a result of alleged Onglyza heart failure side effects, many people may choose to file an Onglyza lawsuit against the drug manufacturers. An Onglyza class action lawsuit investigation has been launched against AstraZeneca and Bristol-Myers Squibb. Plaintiffs may win compensation for suffering from alleged Onglyza side effects which were not warned about by the drug manufacturers.