Liraglutide [rDNA origin] (Victoza)- Risk of Acute Pancreatitis and Thyroid C-cell Tumors
June 14, 2011
Novo Nordisk is reminding healthcare professionals that Victoza (liraglutide [rDNA origin]) injection can potentially cause acute pancreatitis and dose-dependent, treatment duration-dependent thyroid C-cell tumors. Victoza (liraglutide [rDNA origin]) injection is used as an adjunct to diet and physical activity to control blood glucose levels in adults with type 2 diabetes.
Monitor patients for signs of pancreatitis after initiation and dose increases of Victoza (liraglutide [rDNA origin]). Thyroid C-cell tumors were found in rats and mice but human significance is not known at this time. Monitor patients for thyroid nodules and possibly elevated serum calcitonin. Refer to an endocrinologist upon pertinent findings. Report adverse events to FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm or call 1-800-332-1088 to request a form.
The Victoza (liraglutide [rDNA origin]) Risk Evaluation and Mitigation Strategy (REMS) program contains information about the acute pancreatitis risk and potential for thyroid C-cell tumors. The REMS was developed to ensure prescribers are aware of these serious adverse events so they may carefully weigh the risks versus benefits before prescribing Victoza (liraglutide [rDNA origin]).
Additional information is available at the following links:
- MedWatch alert:
- Press Release:
- Dear Healthcare Professional Letter:
June 14, 2011; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.