AUDIENCE: Endocrinology, Family Practice
ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because 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.
Liraglutide 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, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.
BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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