An FDA advisory committee has recommended that the type-2 diabetes medication Onglyza should carry a new warning label that includes the increased risk of heart failure as a possible side effect. The U.S. Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee reviewed the data collected through a study published by the New England Journal of Medicine, as well as the clinical trial data provided by Onglyza manufacturers, before making their decision.

After the review, the FDA committee voted 14-1 that Onglyza should carry a new Onglyza label warning to reflect the increased heart risk with only one committee member voting for a recall of the medication.

While the company is not legally required to follow the recommendations of the expert advisory committee, they usually take their findings into consideration before making a final decision.

What is Onglyza?

The FDA approved the use of Onglyza to treat type-2 diabetes in 2009. Onglyza was designed by AstraZeneca and Bristol-Myers Squibb, but is now strictly owned by AstraZeneca. It is part of a class of drugs known as incretin mimetics.

The 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 type-2 diabetes medications.

Onglyza had a revenue of $700 million in 2012 and drug analysts predicts a total profit of $2.47 billion by 2018.

Onglyza Complications

Although it is widely prescribed, the type-2 diabetes medication has been linked to several serious health risks including heart failure, pancreatic cancer, and thyroid cancer.

The New England Journal of Medicine published a study after analyzing 16,492 type-2 diabetes patients who were given either Onglyza or a placebo. Researchers discovered that Onglyza patients had a 27 percent increased risk of heart failure compared to those on a placebo. 

In addition to heart failure, other studies have found a link between Onglyza and pancreatic cancer. In 2013, researchers studied the autopsies of diabetes patients, including those who took an incretin mimetic like Onglyza. Those patients taking an incretin mimetic had a pancreas that was 40 percent larger than normal. Researchers also found that those patients also had pre-cancerous cell growth and small tumors in the pancreas as well.

Another study by Johns Hopkins researchers found that diabetes patients hospitalized with pancreatitis were twice as likely to be taking an incretin mimetic drug like Onglyza at the time they were admitted.

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

Onglyza Lawsuits

Due to the increase of research that suggests Onglyza side effects may be more serious than drug makers warned about, hundreds of incretin mimetic drug lawsuits have been filed so far.

If you suffered from one of the serious Onglyza side effects you may be able to file a lawsuit in order to financially recover from medical bills as well as other damages. Contact a Onglyza attorney to find out if you have legal claim.