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Possibility of Pancreatitis in Patients Taking Byetta

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FDA is alerting healthcare professionals that Byetta (exenatide) may be associated with acute pancreatitis in some patients. Byetta is administered subcutaneously to treat type 2 diabetes.

FDA has reviewed 30 reports of acute pancreatitis in patients taking Byetta. Twenty-one were hospitalized, five of them with serious complications. Twenty-two of the patients improved after discontinuing the drug.

Practitioners should be alert to the signs and symptoms of pancreatitis in patients taking Byetta. If pancreatitis is suspected, discontinue the drug. If the diagnosis is confirmed, do not restart Byetta unless an alternative cause for the pancreatitis is identified.

Patients taking Byetta should be cautioned to promptly seek medical care if they experience symptoms of pancreatitis, such as persistent and severe abdominal pain, possibly accompanied by vomiting.

The manufacturer of Byetta, Amylin Pharmaceuticals, has agreed to include information about pancreatitis in the Precautions section of the drug's labeling.

 

Additional Information:

FDA MedWatch Safety Alert. Byetta (exenatide). October 16, 2007

FDA: Information for Healthcare Professionals - Exenatide (marketed as Byetta)

FDA: Exenatide information

 

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