FDA, EMA Review Pancreatic Safety of Incretin-Based Drugs

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FDA, EMA Review Pancreatic Safety of Incretin-Based Drugs
FDA, EMA Review Pancreatic Safety of Incretin-Based Drugs

(HealthDay News) — Incretin-based drugs seem not to have a causal association with pancreatitis or pancreatic cancer, according to research published in the Feb. 27 issue of the New England Journal of Medicine.

Amy G. Egan, MD, MPH, from the U.S. Food and Drug Administration in Silver Spring, MD, and colleagues reviewed data relating to blood glucose-lowering drug products that stimulate postprandial insulin released by potentiating the incretin hormone pathways.

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The researchers found that reevaluation of more than 250 toxicology studies yielded no findings of overt pancreatic toxic effects or pancreatitis. Similar results were found on assessment of studies for incretin-based drugs currently authorized for use in the European Union.

In studies requested by the FDA involving a rodent model of diabetes, there was no evidence of treatment-related adverse effects on the pancreas. FDA review of clinical study databases, including more than 200 trials, and European Medicines Agency (EMA) review of all studies performed in the European Union provided no compelling evidence of an increased risk of pancreatitis or pancreatic cancer.

Inconsistent results were found on FDA and EMA review of observational studies assessing the correlation between incretin-based drugs and acute pancreatitis.

RELATED: Pancreatic Cancer Resource Center

"Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data," the researchers wrote.


  1. Egan AG, Blind E, Dunder K, et al. Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment. N Engl J Med. 2014; 370:794-797.

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