Label Changes for:

Janumet (sitagliptin/metformin HCl) tablets 

December 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2009

WARNINGS and PRECAUTIONS 

  • There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking Janumet. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Janumet. 

ADVERSE REACTIONS 

Postmarketing Experience 
  • Hypersensitivity reactions include...cutaneous vasculitis...acute pancreatitis, including fatal and non-fatal hemorrhagic and necrotizing pancreatitis

PATIENT COUNSELING INFORMATION 

  • Patients should be informed that acute pancreatitis has been reported during postmarketing use of Janumet. Patients should be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue Janumet and contact their physician if persistent severe abdominal pain occurs
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