Side Effects of Onglyza May Include Increased Risk of Pancreatitis, Pancreatic Cancer

Side effects of Onglyza may include an increased risk of pancreatitis and pancreatic cancer, according to a recent study published in the journal Diabetes Care.

The pancreas is an organ that produces enzymes and hormones that aid in the digestion of food. Insulin is the hormone that regulates glucose, which is the body’s version of sugar that provides cells with the energy they need.

When the pancreas makes an insufficient amount of insulin or the body doesn’t use it correctly, the glucose stays in the blood instead of being delivered to the cells. The result is high blood sugar.

Onglyza is the brand name of saxagliptin, a medication prescribed to control blood sugar levels that are often a problem in patients diagnosed with type 2 diabetes. This drug belongs to a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, which also include sitagliptin, linagliptin, vildagliptin and gemigliptin. Patients who suffer from severe hyperglycemia (high blood sugar) are most often prescribed DPP-4 medications.

According to the recent Onglyza study published in Diabetes Care, the Korean National Health Insurance Service-Health Screening Cohort database was examined by researchers who found that 1,084 patients developed pancreatitis at a rate of 1,073 per 100,000 person-years for DPP-4 users compared with 935 per 100,000 person-years of non-users of DPP-4 medications. Pancreatitis is inflammation of the pancreas, which can cause severe pain and may be life-threatening.

The same group reported 237 patients who developed pancreatic cancer. The users of DPP-4 developed pancreatic cancer at an incidence rate of 236 per 100,000 person-years compared with 200 per 100,000 non-users of DPP-4 drugs. The length of time the patient was taking the prescription did not appear to influence either the risk of pancreatitis or pancreatic cancer.

Researchers recommended further studies be done to determine the extent of the effects of Onglyza and other DPP-4 inhibitors on the pancreas.

FDA Cautions on Side Effects of Onglyza

The U.S. Food and Drug Administration (FDA) approved Onglyza in July 2009 and Kombiglyze XR in November 2010. Kombiglyze XR contains both saxagliptin and metformin hydrochloride.

In 2014, the FDA issued a warning regarding the potential increased risk of serious and possibly fatal heart side effects of Onglyza. At that time, two different studies indicated patients taking Onglyza could be at increased risk of heart failure, cardiac failure, congestive heart failure, or death.

Published in the New England Journal of Medicine, the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) clinical study looked at 16,492 patients who had type-2 diabetes along with cardiovascular disease or were at a generally higher risk to experience cardiovascular disease.

SAVOR-TIMI 53 found patients taking Onglyza had an increased risk of requiring hospitalization for a heart failure episode that they had not previously experienced, and a potential increased risk of death overall. Any prior history of heart failure or kidney issues was identified as an additional risk factor.

In 2016, the FDA added warnings about heart failure risk to Onglyza and other type-2 diabetes medications containing saxagliptin and alogliptin.

With the discovery that Onglyza may also be linked to an increased risk of pancreatitis and pancreatic cancer, the list of serious and potentially deadly side effects continues to grow.