Byetta, Januvia, Janumet and Victoza
Byetta, Januvia, Janumet and Victoza are prescription medications indicated for the treatment of diabetes. Byetta and Victoza belong to the glucagon-like peptide 1 (GLP-1) class of drugs. GLP-1 therapies mimic a hormone called GLP-1 to stimulate natural insulin production in diabetics. Januvia and Janumet belong to the dipeptidyl peptidase-4 (DPP-4) class of drugs. Januvia and Janumet reduce glucose by inhibiting the enzyme, dipeptidyl peptidase-4. All four medications are also commonly referred to as incretin mimetics.
Byetta was first approved by the United States Food and Drug Administration (FDA) for sale in the U.S. in April 2005. Byetta is manufactured by Eli Lilly. Januvia and Janumet followed shortly thereafter in October 2006 and March 2007, respectively. Januvia and Janumet are manufactured by Merck. Victoza is the newest GLP-1 available in the U.S. and was approved in January 2010. Victoza is manufactured by Novo Nordisk.
Since gaining approval, millions of people in the United States have been prescribed one of these four diabetes medications. Januvia is the bestselling drug in the incretin mimetic class. In 2011 alone, roughly 2 million prescriptions were written for Januvia in the U.S., and that number is expected to continue to climb in the coming years. Januvia’s sales have allowed Merck to corner approximately 75% of the market share for this class of medications.
According to the FDA, Byetta, Januvia, Janumet and Victoza have been linked to side effects including acute pancreatitis, including severe forms of hemorrhagic pancreatitis and necrotizing pancreatitis. Hemorrhagic pancreatitis is inflammation of the pancreas with associated bleeding, and necrotizing pancreatitis occurs when the inflamed pancreas destroys itself.
Symptoms of hemorrhagic and necrotizing pancreatitis include fever, lack of appetite, anorexia, nausea and vomiting, pale stool, rapid pulse, and severe abdominal pain, which may radiate to the back. Cases of hemorrhagic and necrotizing pancreatitis may be fatal.
Pancreatitis can also lead to pancreatic cancer. Pancreatic tumors can grow without a patient exhibiting any symptoms and therefore may not be detected until the cancer reaches a late stage. The American Cancer Society notes that the average rate of survival is 18 to 20 months, and the overall five-year survival rate is only 4 percent.
The uncertainty surrounding incretin mimetic drugs has prompted FDA regulatory action and calls for additional safety studies of these medications.
In 2009, the FDA issued a safety alert warning that individuals using Januvia and Janumet may be at increased risk of suffering acute pancreatitis. The FDA commented that no safety studies were conducted in people who have a prior history of pancreatitis, and the agency warned that it is not known whether these people are at an increased risk of developing pancreatitis if they take Januvia or Janumet.
In 2011 alone, the FDA received over 200 adverse event reports of pancreatitis, including a number of fatalities, involving Januvia.
A recent study conducted at the University of California Los Angeles (UCLA) and published in the medical journal Gastroenterology found that individuals using Januvia and Byetta were at double the risk of suffering pancreatic cancer as non-users, and that both drugs were also associated with an increased risk of pancreatitis and thyroid cancer. According to the study, these risks increase the longer a patient is taking Januvia or Byetta. The study was based on an analysis of reports made to the FDA Adverse Event Reporting Database between 2004 and 2009.
Byetta/Januvia/Janumet/Victoza Litigation & Trial Update
In August 2013, the Judicial Panel on Multidistrict Litigation (JPML) centralized all Byetta, Januvia, Janumet and Victoza lawsuits filed in federal court in In Re: Incretin Mimetics Products Liability Litigation, MDL No. 2452 before the Honorable Anthony Battaglia in the United States District Court for the Southern District of California.
Prior to centralization, Judge Battaglia was overseeing numerous Byetta and Januvia cases as part of an informal consolidation due to the large number of claims that had been filed in the Southern District of California. The JPML ordered centralization noting that it is “typically hesitant to centralize litigation against multiple, competing defendants which marketed, manufactured and sold similar products,” however, the plaintiffs in these cases made “highly similar allegations about each of the four drugs.”
At last count, there were over 650 cases filed in the MDL.
Discovery is currently underway in the MDL. Millions of pages of documents produced by Merck, Eli Lilly and Novo Nordisk are being reviewed. Depositions of key corporate employees for each of the defendants are taking place. The parties are also developing expert testimony to be used at the first incretin mimetic trials in the country. At this time, no trial dates have been set as the parties focus on completing discovery.
If you or a loved one used Byetta, Januvia, Janumet and Victoza and have been diagnosed with pancreatic cancer, pancreatitis or thyroid cancer, you may be entitled to pursue a claim against the manufacturer for these injuries. For a free and confidential case evaluation, please call our office toll-free at (888) 747-5342 or complete our online contact form and we will promptly respond to your inquiry.