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Januvia Study Information

Januvia Study Information

Januvia works by forcing the pancreas to make more insulin, which lowers blood-sugar levels. Unfortunately, recent studies suggest that it could double the risk of pancreatitis (pancreas inflammation) or cause pre-cancerous growths that lead to pancreatic cancer.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

Overview

Januvia (sitagliptin) helps adults with type-2 diabetes control blood-sugar levels. It belongs to a class of drugs called incretin mimetics, which increase hormones that tell the pancreas to make more insulin. Because Januvia relies so heavily on the pancreas, many experts are concerned it could increase the risk of pancreatic side effects.

Diabetes Study Finds Pre-Cancerous Growths in Pancreases

In March 2013, Diabetes published a study linking incretin therapy and pre-cancerous pancreatic growths that could become malignant or require surgery. The researchers autopsied 8 pancreases from adults with diabetes, including 7 from patients on Januvia and 1 patient on Byetta for at least a year.

The pancreases were 40% larger than normal due to exocrine cell proliferation (most pancreatic cancer start in exocrine cells). However, many of the cells were “eccentrically shaped.” Three of the pancreases had microadenomas or neuroendocrine tumors, which could lead to pancreatic cancer.

At the very least, researchers warned that patients may require surgery:

“Since the standard of care of a pancreatic neuroendocrine tumor, because of the risk of conversion to malignancy, even if benign, is surgical resection, patients exposed to incretin therapy would seem to be at increased risk of requiring pancreatic surgery.”

In response to the study, the FDA issued a Safety Communication for Januvia and opened an investigation. However, the agency did not require drug-makers to strengthen warnings about pancreatic cancer.

JAMA Study Finds Doubled Risk of Pancreatitis

In February 2013, JAMA Internal Medicine published a study linking incretin therapy with a doubled increased risk of pancreatitis. Conclusions were based on data from 81 diabetic adults who were hospitalized with pancreatitis after using Januvia or Byetta between 2005-2008.

This is not the first time Januvia has been linked to pancreatitis. In 2009, the FDA issued a Safety Alert after receiving 88 reports of acute pancreatitis. Several patients developed hemorrhagic and necrotizing pancreatitis, the most life-threatening type of pancreatitis.

Gastroenterology Study Links Januvia and Pancreatitis, Pancreatic Cancer

One study that has received a lot of attention was published in February 2011 in Gastroenterology. Researchers from UCLA analyzed case reports that were voluntarily submitted to the FDA from 2004 until 2009.

Januvia was linked to a 6.4-fold increased risk of pancreatitis based on 131 reports. It was also linked to a 2.9-fold increased risk of pancreatic cancer based on 15 reports.

The researchers were concerned about other recent studies that had found higher rates of pancreatitis in rodents treated with drugs that were similar to Januvia. There was also concern that inhibiting DPP-4 could lower the body’s defense against all cancers.

However, because the number of reports was small, the risk can’t be extrapolated to the general population. Instead, it is a signal of a potential risk that should be investigated further. According to the researchers:

“This analysis of the FDA database does not establish that pancreatitis, pancreatic cancer and thyroid cancer are caused by GLP-1 therapy. It simply raises the level of concern that they may be, and that the appropriate prospective studies are required to rule them out.”

Soon after the study was published, the editor-in-chief of the paper received a letter from Amylin Pharmaceuticals and Eli Lilly & Co. (the manufacturers of Byetta, another drug that was studied in the paper). The letter expressed concern that the results in the study were unjustified and the editor was convinced to withdraw the paper.

FDA Warning: Missing Study on Pancreatitis is “Public Health Risk”

In February 2012, Merck & Co. received a Warning Letter from the FDA for failing to perform an agreed-upon study of pancreatitis from Januvia. The FDA asked Merck to conduct the study in 2009, shortly after Januvia was linked to dozens of reports of pancreatitis.

In the warning letter, the FDA called the missing study a “public health risk” due to the unknown risk of pancreatitis:

“Your product is considered misbranded … You have failed to comply with the approved timetable and periodic report submissions … and failed to show good cause for not conducting the additional testing required to further assess whether a signal of a serious risk of acute pancreatitis, including necrotizing forms, associated with the use of sitagliptin, represents a public health risk.”

Do I have a Januvia Lawsuit?

The Schmidt Firm, PLLC is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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