FDA Investigating Possible Link Between Pancreatitis and Diabetes Drugs

WASHINGTON, D.C. — The Food and Drug Administration has announced it is investigating researchers’ findings that a group of new diabetes drugs, including Januvia and Byetta, can cause an increased risk of pancreatitis and pre-cancerous cellular changes known as pancreatic duct metaplasia in patients with type-2 diabetes.

In a March 14 Drug Safety Communication, the agency cited a study in which academic researchers examined a small number of pancreatic tissue samples taken from patients treated with Januvia or Byetta after they died from unspecified causes (see HarrisMartin’s Drugs & Medical Devices Report, February 2013). The FDA has asked the researchers …