Concerns over the safety of a class of type 2 diabetes drugs known as incretin mimetics – glucagon-like peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors – took a sharp turn recently after an investigative report by British media revealed that it uncovered unpublished data that links the drugs to “unwanted proliferative or inflammatory pancreatic effects,” and that drug regulators in the United States and Europe have not responded quickly enough to studies that suggest these drugs are not as safe as manufacturers claim.
Incretin mimetic drugs include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal.
The U.S. Food and Drug Administration (FDA) announced last March that it was looking into the drugs based on unpublished findings from a group of academic researchers who examined a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. The agency had previous warned that cases of acute pancreatitis, including fatal and nonfatal cases, have been associated with the use of incretin mimetic drugs exenatide (Byetta) and sitagliptin (Januvia), and that studies have shown the drugs could as much as double the risk of acute pancreatitis.
Incretin therapies have been hailed as the biggest breakthrough for the treatment of type 2 diabetes since insulin. Not only do they help control blood sugar levels, they also have been found to suppress appetite. Makers of the drug are hoping to win FDA approval to market the medication to overweight people who do not have diabetes.
However, news of dangerous side effects – acute pancreatitis as well as pancreatic cancer and thyroid cancer – have led many people to wonder if the drugs are as beneficial as once thought.