A number of diabetes medications, including Byetta and Januvia, are being probed by the U.S. Food and Drug Administration (FDA) over links to pancreatic cancer.
Diabetes drugs manufactured by Merck & Company Inc., AstraZeneca PLC, and other drug makers are involved over claims that their drugs, when compared to other diabetes drugs, are 25 times likelier to increase pancreatic cancer rates, said Law360. Watchdog group, the Institute for Safe Medication Practices (ISMP) reviewed a year of adverse event reports made to the FDA related to five Type 2 diabetes medications, including Januvia, manufactured by Merck; Byetta, manufactured by AstraZeneca and Bristol-Myers Squibb Co.; and Tradjenta, made by Eli Lilly & Co., said Law360.
The research revealed, said ISMP, 105 cases of pancreatic cancer reported in patients taking these drugs compared to two cases in a different diabetes drug class. Two injectable medications were found to be 28 times likelier to be linked to pancreatitis; three oral drugs were 20 times likelier to be linked to the same condition, said the ISMP, according to Law360. “These data and other recent studies establish the need to reassess the safety of this class of drugs,” the ISMP said.
This March, the FDA initiated a probe based on a medical journal study that revealed the drugs, in a class known as incretin mimetics, may lead to an increased risk of pancreatitis and precancerous cellular changes (pancreatic duct metaplasia), said Law360. The European Medicines Agency (EMA), Europe’s top drug watchdog group initiated its own recommendation following the FDA’s probe.
Incretin mimetic drugs 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). These drugs increase certain natural substances that lower raised blood sugar levels. Diabetics typically have abnormally low insulin levels or their bodies have difficulties utilizing insulin efficiently.
Incretin mimetic drugs imitate the body’s incretin hormones. These hormones are meant to stimulate insulin release following consumption of meals and are typically used in collaboration with diet and exercise to lower blood sugar in adults diagnosed with Type 2 diabetes. In 2009, the FDA required a label update on these drugs warning of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer.
Pancreatitis is an inflammation of the pancreas that is linked to cancer and kidney failure. Chronic pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer. The serious side effects linked to 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.
The ISMP did point out that a drug being mentioned on an FDA adverse event report does not mean that the drug directly causes a condition; however, “[c]onsidered as a group, these data provide a signal for pancreatic cancer substantial enough to warrant further investigation,” the group said. The group did recommend the FDA increase prescribing information for incretin mimetics, according to Law 360.
Merck has been targeted in a wrongful death lawsuit being heard in Illinois state court this March that alleges three people developed pancreatic cancer due to their taking Januvia. Plaintiffs in those lawsuits claim that Januvia has a defective design and lacks adequate warnings about its alleged association with a significantly increased risk of developing pancreatic cancer, said Law360.
Prior research also revealed that Januvia and Byetta have been associated with reports of increased risks for pancreatic and thyroid cancers. Another new study also found that the drugs may double patients’ risks for developing pancreatitis, the first time a study put a number to the risk. In the United States, about 8.6 percent of the population—25 million people—were diagnosed with diabetes in 2010, based on prior Bloomberg News data. That number is expected to rise to more than 34 million by 2020.