Research shows the antidiabetic drug sitagliptin phosphate—sold under the brand name Januvia and as Janumet when combined with metformin—causes acute pancreatitis and pancreatic cancer. The Rottenstein Law Group, a Januvia law firm, compassionately advocates for those who have suffered Januvia side effects. If you’ve taken Januvia and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Januvia recalls and Januvia class action lawsuits.
What Is Januvia and What Is It Prescribed For?
Januvia is the brand name for the drug sitagliptin phosphate. Made and sold by American pharmaceutical giant Merck & Co., Inc. this prescription medication is used to treat type 2 diabetes mellitus. The U.S. Food and Drug Administration (FDA) first approved Januvia in October 2006 in the form of oral tablets containing between 25 mg and 100 mg of sitagliptin phosphate. The FDA approved Janumet in 2007.
Januvia is an antihyperglycemic from the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class. DPP-4 is an enzyme that breaks down two types of intestinal hormones called incretins, GLP-1 and GIP. The human body releases these hormones during meals. Januvia reduces levels of the two incretins, leading to increased insulin and decreased blood sugar levels.
Januvia Might Cause Acute Pancreatitis and Pancreatic Cancer
On September 25, 2009, the FDA announced it was revising Januvia’s and Janumet’s label information. According to the agency, between October 2006 and February 2009, 88 people taking Janumet reported developing acute pancreatitis, and of them two had hemorrhagic or necrotizing pancreatitis. Fifty-eight of the 88 required hospitalization, of which four went into intensive care. Nineteen of the 88 patients developed pancreatitis within 30 days of starting Januvia, and 47 of the 88 patients’ symptoms receded when they stopped taking the drug. Other acute pancreatitis risk factors such as obesity, high cholesterol, and high levels of triglycerides appeared in 45 of the adverse event reports. The FDA stated, “Based on the temporal relationship of initiating sitagliptin or sitagliptin/metformin and the development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events.”
The FDA revised Januvia’s label to include information about acute pancreatitis, recommend doctors monitor their patients’ pancreases, and warn users that to date no one has researched the effects of Januvia on users who already have a history of pancreatitis. Symptoms of acute pancreatitis include:
- Anorexia; and
- Persistent severe abdominal pain that sometimes radiates to the back.
In July 2011, researchers at the University of California, Los Angeles studied the connection between Januvia and pancreatitis and pancreatic cancer by combing the FDA’s adverse events reporting system. They calculated that Januvia increased the risk of pancreatitis by six times, and they found that it also increased the risk of pancreatic cancer by 2.7 times. The lead researcher, Dr. Peter Butler, cautioned that the results do not account for increased Byetta side effects reporting by doctors. The study appeared in the journal Gastroentereology.
On March 14, 2013, the FDA issued a drug safety communication informing the public that it is evaluating unpublished findings by researchers indicating that connected Januvia with pancreatitis and cellular changes called “pancreatic duct metaplasia.” The agency is requesting the researchers provide it with their research methodology and tissue samples they used.
Due to the growing number of Januvia lawsuits, in late July 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard arguments by Januvia users who were suing Merck, as well as from users of similar incretin mimetic drugs, to consolidate their cases into a multidistrict litigation (MDL). The JPML was hesitant to merge cases brought against multiple manufacturers, but it determined that there were sufficient common issues of fact and law to make the consolidation worthwhile. The JPML transferred the MDL to the U.S. District Court for the Southern District of California before Judge Anthony J. Battaglia. It is captioned IN RE: Incretin-Based Therapies Products Liability Litigation (MDL – 2452).
RLG’s Januvia Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Januvia lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Januvia lawsuit on your behalf if necessary. RLG will also keep you up to date on any Januvia class action lawsuits, FDA Januvia warnings, and Januvia FDA recall announcements.
If you’ve taken Januvia and believe it harmed you, contact RLG today for a free, confidential legal consultation.