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FDA: Safety Labeling Changes for Byetta Injections
WARNINGS and PRECAUTIONS
Acute Pancreatitis
•Based on postmarketing data Byetta has been associated with acute pancreatitis, ncluding fatal and non-fatal hemorrhagic or necrotizing pancreatitis. After initiation of Byetta, and after dose increases, observe patients carefully for signs and symptoms of ancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting). If pancreatitis is suspected, Byetta should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Byetta should not be restarted. Consider ntidiabetic therapies other than Byetta in patients with a history of pancreatitis.
Renal Impairment
•Byetta should not be used in patients with severe renal impairment (creatinine clearance < 30 mL/min) or end-stage renal disease and should be used with caution in patients with renal transplantation [see Use in Specific Populations (8.6)]. In patients with end-stage renal disease receiving dialysis, single doses of Byetta 5 mcg were not well-tolerated due to gastrointestinal side effects. Because Byetta may induce nausea and vomiting with transient hypovolemia, treatment may worsen renal function. Caution should be applied when initiating or escalating doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).
Macrovascular Outcomes
•There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Byetta or any other antidiabetic drug.
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