Issue: April 2013
March 14, 2013
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FDA to investigate data on incretin mimetics for pancreatitis, cancer risk

Issue: April 2013
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The FDA has announced they will investigate findings that suggest an increased risk for pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with incretin mimetics.

The findings were based on a study conducted by researchers at the Johns Hopkins University School of Medicine, published in JAMA Internal Medicine on February 25.

According to a drug safety communication press release issued by the FDA, the researchers will be asked to provide the methodology used to collect and study the small number of pancreatic tissue specimens taken from patients after they died due to unspecified causes. The agency will further investigate the potential risk suggested by their published findings.

However, the FDA cautions patients to continue taking their medication as directed by their health care provider. Clinicians are advised to report any adverse events involving incretin mimetics to the FDA MedWatch program.

For more information:

FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes. Accessed March 14, 2013.

Singh S. JAMA Intern Med. 2013; doi:10.1001/jamainternmed.2013.2720.