Type 2 diabetes medications in the class known as incretin mimetics, such as Januvia and Byetta, are under increased scrutiny over recent studies discussing the drugs’ links to pancreatitis and potential increased risks to pancreatic cancer. The makers of these Type 2 diabetes medications may be asked to present additional safety data on the drugs.
The drug makers continue to assert their products’ safety, according to Bloomberg News; however, the U.S. Food and Drug Administration (FDA) may seek to create a study to better understand if medications in the incretin mimetic class may lead to pancreatic cell growth, a typical precursor to cancer. One option, according to FDA spokeswoman, Morgan Liscincky, could be a large, clinical trial that would look at adverse event patterns.
The medications—so-called “incretin mimetics” include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin).
Incretin mimetics increase natural substances that lower raised blood sugar levels. Typically, patients with Type 2 diabetes are either diagnosed with abnormally low insulin levels or their bodies do not utilize insulin efficiently. The drugs imitate the body’s incretin hormones. These hormones are meant to stimulate insulin release after consuming a meal. Incretin mimetics are usually prescribed in addition to life changes that include incorporating a healthier diet and exercise, all meant to lower blood sugar in adults diagnosed with Type 2 diabetes.
The drugs have known risks and labeling changes for incretin mimetics followed Bristol-Myers Squibb’s release of Byetta to the market and the medication being tied to the death of six patients. In 2009, the FDA issued a similar warning for Januvia. The label updates on these drugs warn of increased risks of developing acute pancreatitis (inflammation of the pancreas), which has prompted concern from the medical community.
Pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer, The disorder has also been linked to kidney failure and other serious side effects associated with these Type 2 diabetes drugs include low blood sugar; anaphylaxis and other allergic reactions, such as hives, rash, swelling of the face, lips, tongue, and/or throat; diseases of the pancreas such as acute, necrotizing, or hemorrhagic pancreatitis; pancreatic cancer; thyroid cancer; vomiting and nausea; anorexia; persistent, severe abdominal pain, sometimes radiating to the back; and death.
A 2013 review of insurance records raised concerns of increased risks for pancreatic cancer in patients taking incretin mimetics and prompted the agency to take a closer look at that data. This week, drug makers, FDA officials, and the National Institutes of Health (NIH) are meeting; drug makers are expected to present safety data and the groups will be discussing the potential need for additional safety data. “We need some calm heads and to look at the data and try and make some reasonable judgments out of this” Robert Ratner, chief scientific and medical officer of the American Diabetes Association told Bloomberg News.
This February, research published in JAMA Internal Medicine revealed that patients who were hospitalized for pancreatitis were twice as likely to be taking either Januvia or Byetta in comparison to people diagnosed with diabetes who did not have pancreatitis, according to Bloomberg News. This March, other research published in Diabetes, the Journal of the American Diabetes Association, conducted on the pancreases of patients diagnosed with diabetes, revealed a 40 percent increase in cellular changes that could lead to cancer in people taking incretin mimetics.