“A motion was filed with the United States Judicial Panel on Multidistrict Litigation (JDML) to consolidate all pancreatic cancer lawsuits filed by patients who used Januvia, Janumet, Byetta and Victoza,” Malik says. “These are all new types of diabetic medications called incretin mimetics. To date, there are approximately 53 lawsuits in seven different US district courts that allege these medications are linked to pancreatic cancer.”
Incretin mimetics are used to treat type II diabetes. They work by mimicking the action of incretin hormones, which are normally located in the gastro-intestinal tract and stimulate the release of insulin following a meal. Some studies, however, suggest a link between the development of pancreatitis and the use of incretin mimetics. Furthermore, there is a link between pancreatitis and the development of pancreatic cancer.
“In March [3/14/13], the Food and Drug Administration [FDA] launched an investigation into the pancreatic cancer risk and the use of incretin mimetic drugs. What prompted the FDA to begin the investigation were new findings in recent medical studies that found an increased risk of pancreatitis and pre-cancerous changes in the pancreatic gland following the use of the medications,” Malik says.
One study, published in the Journal of the American Medical Association (JAMA; 4/8/13), found that treatment with sitagliptin (Januvia) and exenatide (Byetta) was associated with an increased risk of hospitalization for acute pancreatitis.
Meanwhile, as the FDA began its investigation into incretin mimetics, the European Medicines Agency also launched an investigation into the drugs, Malik says. Back in the United States, plaintiffs wait for the hearing into their application for multidistrict litigation.
“We anticipate the multidistrict litigation hearing will take place in May  at the next JPML hearing in Louisville, Kentucky,” Malik says. “The plaintiffs are pushing for an MDL in the Southern District of California in San Diego. We believe the JPML will find favorably on consolidation in federal court. It usually takes one month after the hearing to get a decision.”
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“This litigation is in its early days, with less than 100 cases filed nationwide,” Malik says. “We believe there could be thousands of cases, even though pancreatic cancer is relatively rare. There are 25 million patients with type II diabetes disease and 85 million with pre-diabetes or folks who are predisposed to it, so the total population at risk is over 100 million. These drugs are being used as first-line therapies as opposed to traditional treatments, but they may hasten the patient’s demise because of the suggested link to pancreatic cancer.”