The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings from a group of academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous cellular changes in patients with type 2 diabetes treated with a class of drugs called “incretin mimetics.”
Many in the medical community are also wary of this new connection. For instance, earlier this month the JAMA Internal Medicine medical journal also wrote a column that urges more research and investigation into the link between this drug class and pancreatic cancer. Specifically of concern are the drugs Januvia or Byetta.
Diabetes control medication is a more than $40 billion in the United States alone. That means there’s big money to be made by pharmaceutical companies that have often neglected patient safety for profit. From clinical trials to physician education, these companies market drugs to become household names often to the detriment of consumers, and excluding other drugs that have been proven to work.
“When a widely-used medication poses a real threat to consumers, it can sadly take years for its true dangers to be put to light,” said Daniel Nigh, a mass torts attorney with Levin, Papantonio. “Actos (another Type II Diabetes drug), for example, was discovered to be immensely more dangerous than originally thought when it came onto the market. Hopefully, drug manufacturers will conduct more thorough initial clinical studies and pre-market assessments before aggressively releasing and promoting their new drugs and making consumers their guinea pigs in the name of quick profits.”
The FDA has previously warned the public of the risks of some drugs in the class of incretin mimetics. For instance, postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, have been associated with the use of exenatide and sitagliptin. A recently published study that examined insurance records also found the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis.
The FDA is continuing to evaluate available data to better understand this potential safety issue. To gather and share more information, the FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute’s (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June.
Ashley Wright is a writer and researcher with Ring of Fire.