Victoza Injection: Risk of Thyroid C-cell Tumors and Acute Pancreatitis

Drug Alerts , News / September 21, 2016

Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS).Liraglutide causes does-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It remains unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans; human relevance could not be ruled out by clinical or nonclinical studies. In addition, clinical trials studying Victoza showed that there were more cases of pancreatitis in patients treated with Victoza than in patients treated with other similar medications.

Victoza in indicated as an adjunct to diet and exercise with the aim of improving glycemic control in adults with type 2 diabetes mellitus.

Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza, if serum calcitonin is measured about found to be elevated, the patient should be referred to an endocrinologist for further evaluation.

After initiation of therapy with Victoza, and following doses increments, patients should be observed carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiation to the back, and which may or may not be accompanied by vomiting).

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