Januvia, Byetta Pancreatitis Risk Not Seen in New Study

A new study by U.S. researchers appears to cast doubt on claims that the side effects of Byetta and Januvia, two drugs used to treat diabetes, increase the risk of acute pancreatitis. 

The research was presented on Monday at the American Diabetes Association’s (ADA’s) 70th Scientific Sessions, being held in New Jersey. The study was conducted by the Medco Research Institute in conjunction with the University of Texas.

Researchers looked at pharmacy and medical claims data collected by the Medco Therapeutic Resource Center for diabetes for more than 786,000 adults between January 2007 and June 2009. According to the researchers, the findings suggest that diabetics in general are at increased risk of acute pancreatitis, which appeared to be independent of their use of Byetta or Januvia.

Patients taking various diabetic medicines overall had 5.72 cases of acute pancreatitis for every 1,000 patient years. The rate of pancreatitis for Byetta patients specifically was 5.69, and the rate of pancreatitis for Januvia patients was 5.54. Overall, diabetics were found to be at twice the risk of acute pancreatitis than non-diabetics, researchers said.

Another study presented at the conference by Medco research failed to find any association between Byetta and kidney failure as well.

Pancreatitis is an inflammation of the pancreas that can cause symptoms like severe upper abdominal pain which 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 pancreatitis lawsuits involving allegations that they failed to adequately research their medication and warn about the risk of pancreatitis from the diabetes drug.

Januvia and Janumet are newer drugs approved for the treatment of adults with Type-2 diabetes. They are 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, generating $462 million in sales worldwide in the second quarter of 2009.

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).