Byetta, Januvia Pancreatic Cancer Side Effects Being Reviewed in Europe

The diabetes drugs Byetta, Januvia, and Victoza are now under investigation by European health officials due to possible ties to pancreatic cancer and pancreatitis. 

On March 26, the European Medicines Agency (EMA) announced that it is looking into potential side effects uncovered by a recent study that also led the FDA to launch a similar investigation earlier this month into the pancreatic cancer risk with the diabetes drugs.

Byetta, Januvia and Victoza, as well as several other drugs, belong to a family of diabetes medications known as incretin mimetics, which mimic the incretin hormones the body uses to stimulate the production of insulin. They are used to lower blood sugar in people with type 2 diabetes.

Both investigations come after a study published last week in the medical journal Diabetes found evidence of increased pancreatic mass and precancerous cells among organ donors with type 2 diabetes treated with incretin mimetics. The findings raise serious concerns about the risk of pancreatitis and the development of cells with the potential to evolve into tumors.

Neither the FDA nor the EMA has made any recommendations in regards to changing the use of the drugs. Both recommend that patients continue to take the drugs as prescribed and that doctors continue to prescribe them in accordance with the product information.

Pancreatitis concerns have circulated around the drugs since 2007, when Byetta was linked to 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.

Concerns about the side effects of Byetta and Januvia were heightened last month, when a study published in JAMA Internal Medicine suggested that taking Byetta or Januvia may double the risk of hospitalization due to pancreatitis and researchers expressed concern that this may ultimately caused some users to develop pancreatic cancer, since chronic pancreatitis is a known risk factor for the development of pancreatic cancer.

A number of former users of the diabetes drugs who have been diagnosed with pancreatic cancer are already pursuing Byetta lawsuits, Januvia lawsuits and Victoza lawsuits, alleging that the drug manufacturers have ignored information about the potential toxicity to the pancreas and failed to warn about the potential pancreatic cancer side effects.