The FDA has launched an investigating into the possibility that diabetics may face an increased risk of pancreatitis and pancreatic cancer from an entire class of diabetes drugs, which includes Januvia, Byetta, Victoza and others.
Following recent studies that suggest a connection between a class of medications known as incretin mimetic drugs and pancreatic cancer, the FDA announced in a drug safety communication issued this week that it has opened an investigation into the drugs’ cancer risks. The FDA has already previously warned that the drugs could be linked to pancreatitis.
Incretin mimetic drugs mimic the incretin hormones that the body uses to stimulate the production of insulin. They are used to lower blood sugar in people with type 2 diabetes. The class includes the drugs Byetta, Bydureon, Januvia, Janumet, Janumet XR, Jentadueto, Juvisync, Kazano, Kombiglze XR, Nesina, Onglyza, Tradjenta, and Victoza.
The study that sparked the FDA investigation was released last month in the medical journal JAMA Internal Medicine. Researchers from Johns Hopkins Hospital in Baltimore, Maryland, found that taking Januvia or Byetta may double the risk of hospitalization due to pancreatitis, raising concerns that many patients may ultimately develop pancreatic cancer.
Studies have also found that pre-cancerous cellular changes occurred in the pancreas of patients given this class of drugs.
Concerns Over Januvia, Byetta Side Effects Raised Years Ago
Januvia (sitagliptin) is a medication approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors, but it is also considered an incretin mimetic drug. It has rapidly become a strong selling medication for Merck, and is also sold in combination with metformin under the brand name Janumet.
Byetta (exenatide) was originally introduced in April 2005, as a twice a day subcutaneous injection administered to help reduce blood sugar levels in type 2 diabetics. Bydureon, a longer-acting version of the medication, was approved in January 2012, allowing users to take one dose a week to regulate their diabetes.
Pancreatitis concerns have circulated around the drugs since 2007, when Byetta was linked to 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.
The risk of pancreatic cancer was first suggested in a 2011 Januvia study that found that the drug may increase the risk of both pancreatitis and pancreatic cancer.
FDA Recommends Continued Use During Investigation
The FDA notes that it has not yet reached any conclusions about the drugs and their safety risks to the pancreas, and are currently advising patients to continue taking their diabetes drugs until they talk with their health care providers. Doctors have been told to continue to follow the prescribing recommendations on the drug labels.
The FDA states it will release a report of final conclusions and recommendations when its investigation and report are complete.
As a result of the potential link between Januvia and Byetta with pancreatic cancer, product liability lawyers are currently reviewing potential claims for failure to warn about the risk. Although chronic pancreatitis is a known risk factor for the ultimately development of pancreatic cancer, the drug makers have failed to adequately warn about the importance of monitoring changes to the pancreas during treatment, according to allegations raised in Byetta lawsuits and Januvia lawsuits.