SAFETY ALERT: FDA Warns of Risk of Thyroid C-Cell Tumors with Victoza
Novo Nordisk and the FDA reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy. A recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza. Victoza causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors in humans, as human relevance could not be ruled out by clinical or nonclinical studies. In clinical trials there were more cases of pancreatitis among patients treated with Victoza than in patients treated with comparators.
The FDA recommends patients should be referred to an endocrinologist for further evaluation if thyroid nodules are noted on physical exams or neck imaging, or if serum calcitonin is elevated. After initiation and dose increases of Victoza, patients should be observed carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting).
Victoza is a once-daily human glucagon-like peptide-1 injection indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm