Diabetes Drugs Januvia, Byetta Double Risk of Pancreatitis

February 26, 2013 — The diabetes drugs Januvia (sitagliptin) and Byetta (exenatide) have been linked to a doubled risk of acute pancreatitis (pancreas inflammation), which is a risk factor for developing pancreatic cancer.

Millions of Americans with type-2 diabetes take Januvia, Byetta, or Janumet (sitagliptin/metformin) to control their blood-sugar levels. The drugs work by increasing levels of glucagon-like peptide-1 (GLP-1), a hormone that stimulates the pancreas to produce more insulin. Unfortunately, this diabetes treatment could increase the risk of sudden inflammation in the pancreas.

Researchers from John Hopkins University in Baltimore published their findings yesterday in the medical journal JAMA Internal Medicine. They compared insurance records on nearly 1,300 people with diabetes who had been hospitalized for pancreatitis, and compared them to the same number of diabetics who did not develop the condition. The study analyzed data from 2005 to 2008.

The researchers found that 87 people filled a prescription for Byetta or Januvia, compared to 58 people in the control group. After controlling for underlying conditions that increase the risk of pancreatitis, they concluded that people who took Byetta or Januvia were twice as likely to develop pancreatitis.

People with diabetes are already at an increased risk of pancreatitis compared to the general population. The disease affects about 3 out of 1,000 people with diabetes, and a doubled risk would translate to about 6 in 1,000 people taking Januvia or Byetta.

Doctors and researchers have been raising concern about the link between GLP-1 therapy and pancreatitis for several years. In 2007, the U.S. Food and Drug Administration (FDA) published a warning about Byetta pancreatitis after receiving dozens of case reports. In 2009, the FDA published a similar warning for Januvia pancreatitis. Although the case reports suggested an increased risk of pancreatitis, the JAMA study is one of the first major studies to evaluate the size of the risk.

There is also concern about the potential link between GLP-1 therapy and cancers of the pancreas and thyroid gland. Pancreatitis is a risk factor for developing pancreatic cancer. Some studies of GLP-1 therapy in rodents have also suggested a potential risk of thyroid cancer. However, these cancers are very rare, and long-term studies are necessary to determine whether Januvia or Byetta increase the risk of cancer.

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