Januvia and Byetta Must Add Data The makers of some Type 2 diabetes medications, such as Januvia and Byetta, may be asked to put together additional data on the drugs’ potential cancer links.
Merck & Co., Novo Nordisk A/S, and others continue to assert their products’ safety, according to Bloomberg News. Meanwhile, the U.S. Food and Drug Administration (FDA) has indicated that it is looking to create a study—either through the agency or the drug makers—to more fully review whether the medications can lead to pancreatic cell growth, a typical precursor to cancer. One option, said FDA spokeswoman Morgan Liscincky, would be a large, clinical trial that would reveal adverse event patterns.
The medications—so-called “incretin mimetic”—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. People with Type 2 diabetes typically have abnormally low insulin levels or their bodies have difficulty utilizing insulin efficiently.
Incretin mimetics imitate the body’s incretin hormones, which are supposed to stimulate the insulin release that occurs after meal consumption. In addition to changes to diet and incorporating exercise to lower blood sugar in adults diagnosed with Type 2 diabetes, incretin mimetics are often prescribed. The drugs are not without established risks.
FDA issued a similar warning for Januvia
Labeling changes for incretin mimetics followed the introduction of Bristol-Myers Squibb’s Byetta, after the medication was tied to the death of six patients. In 2009, the FDA issued a similar warning for Januvia. The label update on these drugs warns of increased risks of developing acute pancreatitis (inflammation of the pancreas), which has prompted increased concern from the medical community.
Pancreatitis is a painful, potentially fatal disorder, a known risk factor for pancreatic cancer, and has been linked to kidney failure. The 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 review of insurance records earlier this year raised concerns of increased pancreatic cancer risks in people taking incretin mimetics, and the agency has been looking more closely at the data. This week, drug makers are meeting with FDA officials and the National Institutes of Health (NIH) to present safety data for these drugs and to review potential, additional safety data.
JAMA Internal Medicine revealed that patients requiring hospitalization for pancreatitis
“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.
Meanwhile, this February, research published in JAMA Internal Medicine revealed that patients requiring hospitalization for pancreatitis were twice as likely to be taking Januvia or Byetta than people diagnosed with diabetes who did not have pancreatitis, according to Bloomberg News. And, in March, 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 cell changes that could lead to cancer in people taking incretin mimetics.