The findings of new research suggest that the popular diabetes drugs Byetta and Januvia could increase the risk of pancreatitis and pancreatic cancer.
In a study published this summer in the medical journal Gastroenterology, researchers from the University of California, Los Angeles (UCLA) found a nearly threefold increase in reported cases of pancreatic cancer and a sixfold increase in reported cases of pancreatitis among Byetta and Januvia users.
Researchers also found an increase in thyroid cancer among Byetta users.
The study used data from the FDA’s adverse event reporting system from 2004-2009 to find reports of problems with Januvia and Byetta submitted by doctors and patients who took the drugs. However, the researchers warn that the study does not provide a causal link between the side effects of Byetta and Januvia and an increased risk of pancreatitis or pancreatic cancer.
Prior studies done on rats have also suggested a potential link between the two drugs and pancreatitis, which is an inflammation of the pancreas that can cause symptoms like severe upper abdominal pain that may radiate through the back, nausea, vomiting, high or low blood pressure, increased heart rates or elevated respiratory rates. Severe cases, involving necrotizing pancreatitis or hemorrhagic pancreatitis, can cause severe bleeding, multi-organ failure or death.
Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.
Concerns about pancreatitis from Byetta first surfaced in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.
Amylin and Eli Lilly currently face a number of Byetta lawsuits involving allegations that they failed to adequately research their medication and warn about the risk of pancreatitis or other side effects of the diabetes drug.
Januvia is a newer drug approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors. Januvia has rapidly become a strong selling medication for Merck.
In September 2009, FDA recommended that doctors monitor patients carefully for signs of pancreatitis from Januvia and Janumet after starting treatment or increasing dosage. The agency found that in 58 of the 88 cases of pancreatitis Januvia and Janumet users required hospitalization, and four required treatment in intensive care units (ICU).