Side Effects of Byetta, Januvia Linked to Risk of Pancreatitis: Study

A new study involving Americans with type 2 diabetes suggests that those who take the drugs Byetta and Januvia may face an increased risk of being hospitalized with acute pancreatitis, resulting in concerns about a potential link between the drugs and pancreatic cancer as well. 

The findings of the study were published this week online by the medical journal JAMA Internal Medicine, providing support for prior research that found there may be a risk of pancreatitis from side effects of Byetta and Januvia.

Researchers from Johns Hopkins in Baltimore found that taking Januvia or Byetta may double the risk of hospitalization due to pancreatitis.

The case-control study looked at 2,538 adults with type 2 diabetes, half of whom were hospitalized with acute pancreatitis. They found a number of factors that increased the risks of pancreatitis, such as smoking, drinking and obesity, but once they adjusted for those factors, they determined that patients who had used Januvia or Byetta in the last 30 days were twice as likely to be hospitalized by acute pancreatitis.

Januvia (sitagliptin) is a medication 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, and it has rapidly become a strong selling medication for Merck.

Byetta (exenatide) was originally introduced in April 2005, as a twice a day subcutaneous injection administered to help reduce blood sugar levels in type 2 diabetics.  Bydureon, a longer-acting version of the medication, was approved in January 2012, allowing users to take one dose a week to regulate their diabetes.

Warnings First Came From FDA Adverse Event Reports

In recent years, FDA adverse event reports have raised concerns about a potential 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.

The latest study comes about a year after the FDA sent a warning letter to Merck, admonishing the drug maker for failing to properly study the risk of pancreatitis from Januvia and Janumet, which combines Januvia with metaformin.

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).

Pancreatitis involves an inflammation of the pancreas, which requires immediate medical attention and may result in the need for hospitalization. The condition is associated with severe upper adbdominal pain, nausea and vomiting. Chronic pancreatitis has been linked to a potential increased risk of pancreatic cancer and other health problems.

As a result of the findings of this latest study, researchers indicate that additional research is needed to evaluate the potential link between Januvia, Byetta and pancreatic cancer

In 2011, a Januvia pancreatic cancer study indicated that the drug may increase the risk of pancreatitis and pancreatic cancer. However, Merck has maintained that a thorough review of clinical trial data has found no evidence of a causal relationship between side effects of Januvia and pancreatic cancer or pancreatitis.