FDA Investigating Pancreatic Risk Associated with Type 2 Diabetes Drugs

FDA investigating pancreatitis risk associated with incretin mimetics including GLP-1 agonists and DPP-4 inhibitors.

On March 14, the FDA announced that it is evaluating research that suggests an increased risk for pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with incretin mimetics such as:
•    Exenatide (Byetta, Bydureon)
•    Liraglutide (Victoza)
•    Sitagliptin (Januvia, Janumet, Janumet ZR, Jivisync)
•    Saxagliptin (Onglyza, Kombiglyze XR)
•    Alogliptin (Nesina, Kazano, Oseni)
•    Linagliptin (Tradjenta, Jentadueto)

The investigation is based on unpublished research from a study of a small number of pancreatic tissue specimens taken from patients after death from unspecified causes.

Currently, no new conclusions about the safety of these drugs have been reached. The FDA has requested methodology used to collect and study these specimens, and the tissue samples used, so it can further investigate.

The FDA said that health care professionals should continue to follow the prescribing recommendations in the drug labels, but they are also encouraged to report adverse events or side effects to the FDA.

To report issues:
•    Complete and submit the report online: www.fda.gov/MedWatch/report.htm
•    Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the FDA Safety Alert