In 2009, the Federal Drug Administration (FDA) approved Onglyza (saxagliptin) to treat patients with type 2 diabetes. In 2010, Kombiglyze XR, a medication that combines saxagliptin and metformin HCL extended release, was approved by the FDA. Both Onglyza and Kombiglyze XR are incretin-based therapies that are part of a large class of type 2 diabetes drugs known as DPP-4 inhibitors.
How Onglyza Works
DPP-4 is a naturally occurring enzyme in the body that breaks down an incretin hormone known as GLP-1. GLP-1 is released after we eat to encourage the pancreas to make insulin. However, in people with type 2 diabetes, GLP-1 is often reduced and the pancreas does not make sufficient insulin to maintain adequate blood sugar levels.
Onglyza, like other DPP-4 inhibitors, blocks DDP-4 in the body which allows GLP-1 to remain in the body longer and thus stimulates a patient’s pancreas to make more insulin. At the same time, the drug reduces a hormone that encourages the liver to make more glucose, or blood sugar. The intended result is for a patient’s blood sugar levels to decrease without the patient gaining significant weight.
Serious Side Effects Reported by Onglyza Users
DPP-4 inhibitors help some people with type 2 diabetes manage their conditions. However, they are not without risks. Onglyza has, for example, been linked to serious and life-threatening conditions such as:
- Pancreatitis: In November 2011, Onglyza’s warning label was revised to indicate an increased risk of pancreatitis while taking this medication. Pancreatitis, or inflammation of the pancreas, can lead to pancreatic cancer or death. The warning was issued because of post-market reports of pancreatitis among Onglyza users.
- Pancreatic cancer: Pancreatic cancer is often fatal because it is difficult to diagnosis until the disease has progressed to a late stage cancer. A study published in March 2013 found that there was an increased risk of pancreatic cancer for patients who took DPP-4 inhibitors. The FDA has been investigating and evaluating this risk since 2013.
- Heart failure: In April 2015, an FDA panel told AstraZeneca that the Onglyza warning label should be revised to warn patients about the potential risk for heart failure. The panel considered the issue of heart failure after a 2013 study of more than 16,000 patients taking Onglyza found a slight increased risk of heart failure among Onglyza patients when compared to other type 2 diabetes patients.
Additionally, in August 2015 the FDA warned that DPP-4 inhibitors, such as Onglyza, can cause “severe and disabling” joint pain. A new warning about this potential risk was added to the drug’s label at that time.
What to Do If You’ve Suffered a Serious Side Effect From Onglyza
All serious side effects should be immediately reported to your doctor. If the side effects result in medical costs, lost time from work, or other damages then it is also important to contact an experienced Kentucky Onglyza lawyer. An attorney can help you understand your rights and fight for your fair and just recovery against AstraZeneca, the maker of Onglyza. For more information or to schedule a free consultation, please start a live chat with us now or call us directly at 502-210-8942.