Diabetes Drugs Januvia and Byetta Linked to Pancreatic Cancer
Recent scientific studies have suggested that two diabetes drugs, Januvia and Byetta, may increase the risk of developing pancreatitis and pancreatic cancer. Januvia and Byetta are in the class of drugs known as GLP-1 based therapies and are used to treat Type 2 diabetes.
In 2011, researchers at UCLA examined FDA “adverse event” reports and found that patients taking Januvia or Byetta were six times more likely to develop pancreatitis, or inflammation of the pancreas, than patients taking other diabetes drugs. The researchers also found that Januvia and Byetta patients had three times the risk of developing pancreatic cancer. A February 2013 study from Johns Hopkins University further found that GLP-1 based therapies more than doubled the risk of hospitalization for acute pancreatitis. The authors noted that the study should raise a red flag because pancreatitis is “on the pathway” for pancreatic cancer, and suggested that further studies be conducted.
Underscoring its concerns about the safety of these diabetes drugs, the FDA issued a Drug Safety Communication on March 4, 2013 stating it is evaluating unpublished findings that suggest an increased risk of pancreatitis and pre-cancerous cellular changes – called pancreatic duct metaplasia – in diabetic patients treated with GLP-1 based therapies such as Januvia and Byetta. The FDA is urging patients and health care professionals to report adverse events involving these drugs to the FDA MedWatch program.
This recent FDA action follows previous actions the agency has taken over concerns about Januvia and Byetta. In September 2009 the FDA required new label warnings about the potential risk of Januvia’s pancreatitis side effects. Also in 2009, the FDA approved a Risk Evaluation and Mitigation Strategy to investigate pancreatitis side effects for Byetta.
Ashcraft & Gerel is investigating cases involving pancreatic cancer or pancreatic duct metaplasia with Januvia or Byetta. If you or a loved one has received either diagnosis while taking Januvia or Byetta, please contact our team of attorneys today.