FDA: Type 2 Class of Diabetes Drugs Linked to Pancreatic CancerApr 22, 2013
Data from the U.S. Food and Drug Administration (FDA) show that the Type 2 class of diabetes drugs – which includes Januvia, Byetta, and Tradjenta – is 25 times more likely to be linked to pancreatic cancer than other diabetes drugs.
The Institute for Safe Medication Practices (ISMP) examined a year's worth of adverse event reports made to the FDA for five Type 2 diabetes drugs, Law360 reports. In that period, the ISMP found 105 reported cases of pancreatic cancer among users of incretin mimetic drugs, which fall into the Type 2 class, compared to two cases of another class of diabetes drugs. The two injectable drugs in the incretin mimetic group were more than 28 times more likely to be linked to pancreatitis, an inflammation of the pancreas; and the three oral drugs were more than 20 times more likely to be linked to the condition, according to the ISMP.
The FDA launched a probe in March based on a medical journal study that found that the class of incretin mimetics may lead to an increased risk of pancreatitis and precancerous cellular changes known as pancreatic duct metaplasia. The European Medicines Agency, Europe's top drug watchdog, began a similar investigation weeks later, Law360 says.
Incretin mimetic drugs include AstraZeneca and Bristol-Myers Squibb’s Byetta; Merck’s Januvia and Janumet; Eli Lilly’s Tradjenta; Novo Nordisk’s Victoza; and Takeda Pharmaceutical’s Nesina, Kazano, and Oseni. These drugs mimic the natural hormones that stimulate the release of insulin in response to a meal. The drugs are used to help lower blood sugar in adults with Type 2 diabetes.
The ISMP explained that although an FDA adverse event report doesn't necessarily indicate that a drug causes a condition, “these data provide a signal for pancreatic cancer substantial enough to warrant further investigation,” according to Law360.