Prescription drugs for type-2 diabetes have grown in popularity exponentially over the last few decades. With tens of millions of patients taking them each year, they’re now among the most widely used on the market.
Besides the standard insulin-based treatments, other formulations have emerged that control blood sugar by manipulating chemicals in the body that regulate it. These include SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.
The most commonly used of the non-insulin based medications are known as incretins, which include GLP-1 agonists and DPP-4 inhibitors. And, while all prescription drugs carry the risk of side effects, this class has repeatedly been associated with one of the most deadly diseases known, pancreatic cancer.
As early as 2009, concerns arose that incretins could be linked to pancreatitis and pancreatic cancer. And, despite nearly 1,000 lawsuits alleging injury or death from this terrible disease, both the FDA and EMA have maintained they are safe. Now, however, new research could re-open the debate into the risk of these drugs.
GLP-1 and DPP-4 Incretin Drugs
The class of incretin diabetes drugs includes GLP-1 receptor agonists like Victoza, Byetta and Trulicty, as well as DPP-4 inhibitors such as Januvia, Onglyza and Tradjenta.
Januvia and Janumet, from Merck, had a staggering $6.1 billion in combined sales last year, while Victoza, from Novo Nordisk, sold $2.8 billion.
GLP-1 medications work by supporting the release of incretins, metabolic hormones that promote insulin production after meals to lower blood sugar levels. DPP-4 inhibitors, on the other hand, work by suppressing Dipeptidyl peptidase-4, the enzyme that deactivates GLP-1.
One of the major differences are that GLP-1s are injectable, while DPP-4s are taken orally.
Unfortunately, several studies have suggested that DPP-4 is not only an essential part of the metabolic process, but it also suppresses the development of tumors and cancer. Therefore, by artificially blocking it, these meds may be increasing cancer risks.
European Study Raises New Incretin Pancreatic Cancer Risks
In October, a wide-reaching study from Europe was published that shed new light on the potential relation of pancreatic cancer to those taking incretin medications.
Researchers from France, Italy and Belgium followed more than 559,000 patients taking various drugs for their type-2 diabetes from 2008 to 2013.
Of these, 525,733 were treating with a non-insulin antidiabetic drug (NIAD), while 33,292 were taking an incretin such as Januvia, Victoza, Tradjenta, Byetta or Trulicity. Doctors then measured the risk of pancreatic cancer in both groups.
What they discovered was shocking: During the first 3 months of treatment, those taking incretins had 3.35 times the risk for pancreatic cancer as those taking NAIDs. After 3 months the risk fell, however, patients taking incretins were still about twice as likely to develop pancreatic cancer as those taking other drugs.
Doctors concluded that recent use of incretins like Januvia, Victoza, Tradjenta or Trulicity was related to an increased risk of pancreatic cancer, and recommended more studies to measure the risk of pancreatic cancer with long-term use of incretins.
Years of Data Linking Incretins to Pancreatic Cancer
Unfortunately, this isn’t the first study to suggest patients taking incretins like Januvia, Victoza, Trulicty, Tradjenta or Byetta may be at a higher risk of the deadly disease.
In 2009, the FDA required the makers of Januvia to add label warnings that the drug may increase the risk of pancreatitis, an inflammation of the pancreas that can be a precursor for pancreatic cancer. However, they stopped short of adding a cancer warning.
Then, in 2011, researchers from UCLA found that patients taking incretins like Januvia had more than 6 times the risk of pancreatitis and almost 3 times the risk of pancreatic cancer.
For several years after, the FDA and other researchers focused on identifying a possible link between incretin medications and pancreatic cancer. In 2013, the American Medical Association advised that incretins could double the risk of pancreatitis, the most common risk factor for pancreatic cancer.
That same year, the American Diabetes Association, British Medical Journal and the FDA all called for new studies to measure the cancer risks of incretin drugs.
However, in November 2013, the FDA and European Medicines Agency both decided that there was not enough evidence linking incretin drugs to pancreatic cancer to add new warnings.
Hopefully, the new research will reopen the debate into incretin drug safety and convince these regulators to add warnings for consumers.
Incretin Drug Pancreatic Cancer Class Action Lawsuit Still Pending
While there are currently no warnings for patients about the potential risks for pancreatic cancer with incretin drugs, those affected do have legal rights.
A special federal multidistrict court, known as MDL -2452, IN RE: Incretin-Based Therapies Products Liability Litigation, has been created in the Southern California Federal Court District under the supervision of U.S. District Judge Anthony J. Battaglia.
This court functions much like a class action lawsuit for Januvia, Victoza, Tradjenta, Byetta and Trulicity patients affected by pancreatic cancer, or their families. However, cases are filed separate from one another giving the victims more influence over their direction and resolution.
At this time, 936 cases are pending in this MDL court. Based on the recent warnings, lawyers expect more patients will come forward to join. Lawyers are helping those affected file claims at no cost.
For more information on the side effects and research related to incretin drugs, or to speak directly with a lawyer, contact DrugNews today.
Boniol, M., et al. Incretin-Based Therapies and the Short-term Risk of Pancreatic Cancer: Results From Two Retrospective Cohort Studies. Diabetes Care. (October 22, 2017). Retrieved from http://care.diabetesjournals.org/content/41/2/286
MDL Statistics Report. JPML. (February 15, 2018). Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-February-15-2018.pdf
The U.S. Food and Drug Administration has identified a troubling number of reports of both pancreatitis and liver damage among patients taking the popular rheumatoid arthritis drug Actemra.
Families suing drug maker GlaxoSmithKline over alleged birth defects from their anti-nausea medication Zofran have raised new charges that the company hid safety data from the FDA and is blocking evidence of false advertising.