Incretin Mimetic Drug Injury
DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.
On March 14, 2013, the FDA issued a communication on “Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas” in Incretin Mimetic drugs including:
- Januvia
- Byetta
- Victoza
- Janumet
Risk of Pancreatic Cancer
At issue is the Type 2 Diabetes medications potential link to an increase in pancreatic cancer.
“FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.”
This is not the first time this class of drugs has had a warning from the FDA. “FDA previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of the incretin mimetic drugs 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.1 The Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. Further, FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.”
The FDA’s investigation may have been prompted by a prominent doctor’s study of the drug class discussed in this New York Times article. Dr. Peter C. Butler, the head of the endocrinology department at U.C.L.A, agreed to do a study funded by Merck, “to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.” The study did not do what Merck had hoped as Dr. Butler’s findings revealed, “…worrisome changes in the pancreases of the rats that could lead to pancreatic cancer.” Read the rest of the article here.
Contact Hensley Legal Group for Help
If you or a loved one has developed pancreatic or thyroid cancer after using one of the following diabetes drugs:
- Januvia
- Byetta
- Victoza
- Janumet
Call Hensley Legal Group today. Don’t wait, you may be entitled to compensation.
DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.