An Onglyza study that analyzed more than 16,000 patients showed that those taking the type-2 diabetes medication have a 27 percent increased risk of heart failure.

The U.S. Food and Drug Administration said it was “not reassured” by the increased risk, and set up an advisory committee to determine if the drug’s warning label should include an Onglyza heart failure caution.

In a 14-1 vote, the FDA advisory committee determined that Onglyza should carry a warning of heart failure on its label. One of the members voted to recall the medication altogether.

The Onglyza study also determined that consumers may increase their overall rate of death by taking the medication. Researchers found that patients who take Onglyza have “a significantly increased risk of all-cause mortality.”

A large trial is underway to determine if another drug in the same class also poses an increased risk of heart problems. Medical researchers claim that if Januvia shows a similar heart failure risk to Onglyza they may be able to determine that the risk is not limited to an individual drug but rather the entire class.

While the FDA did require Onglyza to include the heart failure risk on its label, the manufacturer decided not to pull the drug off the market at this time.

Onglyza Complications

Onglyza was approved by the U.S. Food and Drug Administration in 2009 to treat type-2 diabetes. It is a part of a class of drugs known as incretin mimetics. Onglyza was created by AstraZeneca and Bristol-Myers Squibb but is now strictly owned by AstraZeneca.

The type-2 diabetes medication works by increasing the incretin hormones to stimulate the release of insulin. Based on its ability to increase insulin without causing weight gain, Onglyza quickly became one of the most commonly prescribed treatments for type-2 diabetes.

Onglyza had a revenue of $700 million in 2012 and drug analysts predict a total profit of $2.47 billion by 2018. However analysts also claim that due to the FDA’s concern, sales could drop as much as 50 percent if Januvia does not show similar heart failure risks.

Other Onglyza Side Effects

In addition to heart failure, Onglyza has also been reported to increase the risk of pancreatic cancer and thyroid cancer.

In a study that involved the analyzing of diabetic patient autopsies, researchers found that those taking an incretin mimetic drug like Onglyza had a pancreas that was 40 percent larger than normal. In addition, the study found pre-cancerous growth and small tumors throughout the pancreas.

Onglyza may also be linked to thyroid cancer, as numerous studies have linked other incretin mimetic drugs to that risk. In a study performed by UCLA, researchers found that the incretin mimetic drug Byetta carries a five-times greater risk of developing a thyroid cancer.

Onglyza Lawsuits

The type-2 diabetes drug manufacturers face hundreds of lawsuits that claim Onglyza carried serious health risks that were not fully explained to consumers. Onglyza attorneys expect that even more plaintiffs who have been hospitalized for heart failure will pursue lawsuits.

Family members who have lost a loved one due to Onglyza complications can file a wrongful death lawsuit. Contact an Onglyza lawyer to find out if you have legal claim.