Novo Nordisk issued a letter reminding healthcare professionals of important safety information about the type 2 diabetes drug Victoza (liraglutide [rDNA origin]). The letter was issued 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.
The Food and Drug Administration (FDA) has required Novo Nordisk to communicate the following risk information to potential prescribers. 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, 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.
Because of these risks, Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise.
Thank you for your posting about Novo Nordisk’s efforts to remind physicians about important safety information concerning Victoza® (liraglutide [rDNA origin] injection).  I’d like to stress that the information shared by Novo Nordisk is not new. The REMS program mentioned in your posting was required by the FDA when Victoza® was approved in January 2010, and the FDA approved a modification to the REMS including a revised communication plan in May 2011. It requires Novo Nordisk to remind healthcare professionals of important safety information about Victoza®. It is important for patients and healthcare providers to know that this letter from… Read more »