News Article
Food and Drug Administration Announces Possible Link Between Exenatide and Pancreatitis-Related Deaths
The Food and Drug Administration warned physicians on Aug. 18 to immediately discontinue use of exenatide if pancreatitis is suspected, saying that it has received reports of six cases of necrotizing or hemorrhagic pancreatitis - including two deaths - since October 2007.
At that time, exenatide's (Byetta) labeling was changed to include a precaution about acute pancreatitis. The agency had received 30 reports of acute pancreatitis in patients taking the incretin mimetic for type 2 diabetes. Physicians were advised to discontinue exenatide injections if pancreatitis was suspected.
Now the FDA says that exenatide may also be linked to a more severe form of pancreatitis and again is advising physicians to discontinue the drug if the condition is suspected at all. "There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less-severe form of pancreatitis," said the agency in a posting for health care professionals on its Web site.
In all six of the reported cases, the drug was discontinued. All patients required hospitalization; two died, and four were recovering.
The FDA said it is working with exenatide maker Amylin Pharmaceuticals Inc. to "add stronger and more prominent warnings" about the risk of acute hemorrhagic and necrotizing pancreatitis to the drug's precautions section.
Physicians still can use exenatide, but it should not be started in a patient with a history of pancreatitis, said the FDA.
If pancreatitis is confirmed, the agency advises physicians to initiate appropriate treatment and monitor the patient until recovery. Exenatide should not be started again in that patient, the agency added.
In the previous warning, 21 of the 30 patients were hospitalized; 27 had at least one other risk factor for symptoms of pancreatitis. In six patients, symptoms worsened after the dose was increased from 5 mcg twice daily to 10 mcg twice daily. There were no reports of acute hemorrhagic and necrotizing pancreatitis, according to the FDA.
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