Research into the pancreatic side effects of Onglyza has begun to suggest a possible link between diabetes drug and pancreatitis or pancreatic cancer.

Onglyza (generic, saxagliptin) has been on the market since 2009, when the FDA first approved it as a treatment for type-2 diabetes.

Onglyza is one of a relatively new class of diabetes medications known as incretin mimetics. These diabetes medications work by imitating the function of incretin hormones.

Incretins go to work after a person eats a meal, stimulating cells in the pancreas to make more insulin which in turn stimulates the body’s cells to draw glucose out of the blood, bringing blood sugar levels down. Onglyza and other incretin mimetics are designed to have the same blood sugar lowering effect as naturally-occurring incretins.

Since Onglyza is able to lower blood sugar without stimulating weight gain, it has been particularly popular. Sales of Onglyza reached $820 million in 2014, and at least one projection suggests sales could exceed $2 billion by 2018.

Onglyza and Pancreatic Complications

Research published since Onglyza entered the market has suggested that treatment with incretin mimetics may increase the risk of pancreatitis and pancreatic cancer.

In November 2011, the FDA added a note to the labeling for Onglyza stating that cases of pancreatitis had been reported in conjunction with Onglyza treatment. Pancreatitis itself can be a precursor to pancreatic cancer.

Then in March 2013, the FDA published a Drug Safety Communication warning patients and doctors about the suggested link between incretin mimetics like Onglyza and pancreatic complications.

The agency issued the communication in response to examinations of a small number of samples of pancreatic tissue taken from patients who died from unspecified causes.

Some of that tissue showed evidence of pancreatitis and pancreatic duct metaplasia, a type of cellular change that can precede pancreatic cancer.

The FDA said it had not reached any new conclusions as to the safety risks associated with incretin mimetics like Onglyza. The agency planned to continue to monitor all available data relevant to this issue.

The communication refers to a study published in JAMA Internal Medicine in February 2013. Researchers analyzed medical records of over 2,400 patients with type-2 diabetes.

They found that treatment of diabetes with exenatide, an incretin mimetic like Onglyza, was associated with an increased risk of hospitalization for acute pancreatitis.

A study published the same month as the FDA’s Drug Safety Communication showed similar findings. This study was conducted by researchers from UCLA and the University of Florida and was published online in the journal Diabetes in March 2013.

These researchers examined pancreatic cells from deceased organ donors who had had type 2 diabetes. They found an approximately 40 percent increase in pancreatic dysplasia, or cellular proliferation, in the pancreases of those patients who had taken Onglyza or other incretin mimetics. This increase in cellular proliferation is a risk factor for pancreatic cancer.