Recently, researchers studying the risks and safety of Januvia (sitagliptin) have identified possible increased risks of cancer. Although more Januvia studies are necessary, the FDA has already sent Merck a warning letter for failing to conduct a study of pancreatitis.
Do I Have a Texas Januvia Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by severe side effects, you should contact our lawyers immediately. You may be entitled to compensation by filing a Januvia lawsuit in Texas.
Click here for official resources from Merck & Co. regarding clinical studies of Januvia.
FDA Warning Letter for Missing Januvia Pancreatitis Study
Soon after the FDA published a Safety Communication in 2009 regarding the risk of Januvia pancreatitis, they required Merck to conduct a 3-month study of pancreatitis in rodents treated with Januvia. The study was to be competed by March 15, 2011, and the final report was to be submitted by June 15, 2011. When the FDA rejected Merck’s original proposal for the study, Merck failed to follow-up and submit another proposal or conduct the study.
According to the warning letter, Merck’s failure to conduct the Januvia study amounts to a “public health risk”:
“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.”
Januvia Study in Gastroenterology
In February 2011, the journal Gastroenterology and researchers from the University of California Los Angeles (UCLA) published a Januvia study of adverse event reports that were submitted to the U.S. Food and Drug Administration (FDA) between 2004 and 2009. The researchers were concerned about studies linking similar drugs to higher rates of pancreatitis in rodents. Pancreatitis is a risk factor for developing pancreatic cancer. Furthermore, other studies linked DPP-4 inhibition (the mechanism by which Januvia treats diabetes) to an increased risk of all cancers.
The researchers found the following data and risks from the FDA database:
- Pancreatitis: 131 events, 6.74-fold odds ratio vs. control drugs.
- Pancreatic cancer: 16 events, 2.72-fold odds ratio vs. control drugs.
According to the lead researcher who conducted the Januvia study:
“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.”
Within weeks after Gastroenterology published the Januvia study online, representatives from drug-makers Amylin Pharmaceuticals and Eli Lilly & Co. sent a letter to Anil Rushdi, the editor-in-chief of the journal. The drug companies convinced the journal to withdraw the paper after expressing concerns that the results were unjustified.
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