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Title: FDA Receives More Reports of Acute Pancreatitis in Patients Taking Exenatide
URL: http://www.pslgroup.com/dg/2294FA.htm
Doctor's Guide
August 18, 2008

ROCKVILLE, Md -- August 18, 2008 -- The US Food and Drug Administration (FDA) is reissuing a warning regarding the risk for acute haemorrhagic or necrotising pancreatitis in patients taking exenatide (Byetta).

Since issuing the warning in October 2007, the FDA has received reports of 6 cases of haemorrhagic or necrotising pancreatitis in patients taking exenatide. Of the 6 cases, all patients required hospitalisation, 2 patients died, and 4 patients were recovering at the time of reporting. Exenatide was discontinued in all 6 cases.

Exenatide and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute haemorrhagic or necrotising pancreatitis associated with exenatide from the less severe form of pancreatitis.

If pancreatitis is confirmed, healthcare professionals should initiate appropriate treatment and carefully monitor the patient until recovery. Exenatide should not be restarted.

Physicians should consider antidiabetic therapies other than exenatide in patients with a history of pancreatitis.

Read the complete MedWatch 2008 Safety Summary, including a link to the "Information for Healthcare Professionals" page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta


SOURCE: US Food and Drug Administration

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