As "Pancreatitis Is On The Pathway Toward Pancreatic Cancer", Medical Studies Needed To Determine If GLP-1 Diabetes Medications Linked To Cancers Or Malignancies Involving Pancreas
UPDATE: "Cancer of The Pancreas: Possible Side Effect For Diabetics Who Use Byetta, Januvia, Or Victoza?" (Drug Injury Watch, 6/12/13)
UPDATE: "European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes" (EMA Press Release, 3/26/13)
We last wrote about the relatively new and increasingly popular diabetes medications Byetta and Januvia back in November 2011: "Byetta And Januvia: More Debate About The Possible Increased Risk Of Pancreatitis, Pancreatic Cancer, And Thyroid Cancer".
And our last report about Victoza was in November 2012: "The Drug-Induced Pancreatitis Safety Problem That Hangs Around Victoza Gets Another Look".
Now, with a couple of developments in the first part of 2013, it seems that the pancreatic cancer risk is becoming the real drug safety issue as regards Byetta, Januvia, Victoza, and the other incretin mimetic drugs for type 2 diabetes.
In the last few weeks there has been an FDA alert about these diabetes drugs as well as a new significant medical journal article about a study concerning Byetta and Januvia which both have to do, in part, with the possible association between pancreatic cancer and the use of Victoza, Januvia, Byetta, etc.
First, from the March 14, 2013 "FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes":
The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular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.
Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
This March 2013 drug safety alert points out that "FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics."
Strictly Confidential, No Obligation.
Diabetes drugs in the incretin mimetic class -- and their manufacturers --include:
Byetta, Bydureon (Exenatide / injection) -- Amylin, which was acquired by Bristol Myers Squibb (BMS), which co-markets with Astra-Zeneca (AZ);
Victoza (Liraglutide / injection) -- Novo Nordisk;
Januvia, Janumet, Janumet XR, Juvisync (Sitagliptin / tablets) -- Merck;
Onglyza, Kombiglyze XR (Saxagliptin / tablets) -- BMS / AZ;
Nesina, Kazano, Oseni (Alogliptin / tablets) -- Takeda; and,
Tradjenta, Jentadueto (Linagliptin / tablets) -- Boehringer Ingelheim
Next we move to the most recent medical article to raise the possible link between pancreatic cancer and these newer diabetes drugs, "Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus: A Population-Based Matched Case-Control Study", published online by JAMA Internal Medicine in late February 2013.
From a February 26 Medscape.com report about this JAMA medical journal article, "GLP-1 Mimetics Double Pancreatitis Risk in Diabetics":
But most important, said [Sonal Singh, MD, from Johns Hopkins University School of Medicine, Baltimore, Maryland], the study should raise a red flag because "pancreatitis is on the pathway toward pancreatic cancer." Writing in an accompanying commentary, Belinda Gier, PhD, and Peter Butler, MD, from the Larry L. Hillblom Islet Research Center, University of California, Los Angeles, agree, calling the issue of pancreatic cancer "the real crux of the controversy with regard to the safety of GLP-1–based treatment."
"At present, the GLP-1 class of drugs is heavily promoted (and prescribed) as having purported advantages that outweigh its risks. Singh and colleagues provide a timely reminder that, despite large numbers of underpowered studies claiming the contrary from marketing companies, little is yet known about long-term adverse effects of the GLP-1 class of drugs on the exocrine pancreas," they observe.
We will look for future announcements or drug safety alerts from FDA about the safety of Byetta, Januvia, and Victoza, as well as monitor the leading medical journals for long-term studies examining the development of pancreatic cancer in diabetic patients using these newer diabetes medications.