Novo Nordisk recently sent a letter to healthcare professionals, reminding them about the potential risks of thyroid C-Cell tumors and acute pancreatitis associated with Victoza.
Novo Nordisk recently sent a letter to healthcare professionals, reminding them about the potential risks of thyroid C-Cell tumors and acute pancreatitis associated with Victoza.
Victoza (liraglutide [rDNA origin]) injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FDA requested the letter after a recent assessment of healthcare professionals showed that some primary care providers are not fully aware of the serious risks associated with the drug.
“Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise,” wrote Alan C. Moses, MD, global chief medical officer of Novo Nordisk, in the letter to healthcare professionals.
Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in rats and mice, the letter stated. However, it is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid cancer (MTC), in humans.
In addition, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparative medications, according to Moses. “Use with caution in patients with a history of pancreatitis,” he wrote.
To further assess risks, Novo Nordisk will be monitoring cases of MTC via MTC case series registry to “identify any increase in the incidence of MTC, related to the introduction of Victoza into the U.S. marketplace,” Moses added.