The Pharmaceutical Journal
Vol 279 No 7475 p460
27 October 2007

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FDA issues warning over pancreatitis risk of exenatide

The US Food and Drug Administration has issued a warning to health care professionals over reports of acute pancreatitis associated with the antidiabetic medicine exenatide (Byetta).

Postmarketing reports of acute pancreatitis in patients taking exenatide have been reviewed by the FDA, which suspects an association with the drug in some of the cases.

It is advising health professionals to instruct patients to seek prompt medical care if they experience unexplained persistent severe abdominal pain. If pancreatitis is suspected, exenatide should be discontinued.

The UK summary of product characteristics for Byetta states that cases of pancreatitis have been reported in patients taking the drug since it came to market.

A spokesman for the European Medicines Agency said that the agency was aware of such reports and that the safety of exenatide would be kept under review.