Onglyza Associated with Pancreatitis, Pancreatic Cancer, and Cardiac Issues

The Type 2 diabetes medication, Onglyza (saxagliptin), is often offered as a preferred option for diabetics, along with a healthy lifestyle, including exercise and diet; however, Onglyza has been associated with increased risks for pancreatic cancer and heart issues.

Approved in 2009, Onglyza was released as a collaboration between AstraZeneca and Bristol-Myers Squibb. Onglyza brought in sales in excess of $700 million by 2011 and is in a class of drugs known as glucagonlike peptide-1 (GLP-1)-based diabetes therapies, or incretin mimetics. Incretin mimetics work by copying or “mimicking” the body’s incretin hormones, which naturally stimulate insulin release by the pancreas after food is ingested. Incretin mimetics include natural substances that lower raised blood sugar levels and are used in patients diagnosed with abnormally low insulin levels or patients whose bodies do not utilize insulin efficiently.

Experts believe that, because Onglyza stimulates the pancreas, changes occur in the pancreas. In fact, research published in the medical journal, Diabetes, in 2013 revealed that the pancreatic tissue in individuals who took incretin mimetic drugs revealed increased pancreatic mass as well as cellular changes in the pancreas that were described as precancerous.

Physicians and patients also report pancreatitis and inflammation of the pancreas resulting from Onglyza treatment in patients. Pancreatitis also known as a potential precursor to developing future pancreatic cancer.

Prior research—the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study—Involved FDA Adverse Event Reporting System (FAERS) data from November 01, 1997 to December 31, 2012; at the time, data was aggregated and standardized by the AdverseEvent RxFilter process and revealed 2,527 serious adverse events, which listed Onglyza as a suspect drug. Of these, 1,888 listed Onglyza as the primary suspect, according to AdverseEvents.com. The researchers identified 359 hospitalizations and 52 patient deaths in which Onglyza was indicated as the primary suspect. The most common side effects were rash, pancreatitis, and nausea and it is believed that the adverse reactions seen then have continued to mount.

Pancreatic cancer is known as one of the most deadly cancers and is typically diagnosed at a later stage because symptoms that present earlier in the disease’s progression are nonspecific and typically do not directly indicate pancreatic issues. Sadly, those individuals who are diagnosed with pancreatic cancer usually experience rapid pancreatic cancer progression and a poor prognosis.

Onglyza has also been associated with thyroid cancer and heart failure. Other incretin mimetic medications revealed an increased risk of thyroid cancer in some studies. Because of this, it is believed that incretin mimetics may all have negative thyroid impacts.

Heart failure, which is the body’s inability to pump sufficient blood to meet the body’s demands was also reviewed by the U.S. Food and Drug Administration (FDA), which led to warning labels on Onglyna’s that discuss the increased risk of heart failure.

Other incretin mimetics include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin).

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