FDA Warning: Agency Issues Warning for VictozaMonday, June 20, 2011
The Food and Drug Administration (FDA) issued a warning recently for liraglutide (Victoza) about the possible risks of developing thyroid cancer and acute pancreatitis after a recent assessment showed that some primary care providers were unaware of these risks.
The FDA has developed a Risk Evaluation and Mitigation Strategy (REMS) including a reminder letter from the manufacturer to primary care healthcare professionals likely to prescribe Victoza, and a follow-up direct letter sent six months after the initial reminder. This will be done yearly for the next three years.
Novo Nordisk, manufacturer of the drug, has complied with the FDA’s requests.
According to the FDA’s site, “Novo Nordisk will make the REMS, the direct mail letter, the medication guide, and professional labeling available via a REMS-specific linkage from the Victoza website. The medication guide and professional labeling will also be available via hardcopy from Novo Nordisk representatives and through Novo Nordisk’s Call Center.”
The FDA has the authority to create a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.
The reminder letter will be sent within 60 days of the approval of the REMs modification.
In speaking to the Victoza’s warning, the FDA stated, “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.”
Source: Food and Drug Administration Press Release
Originally posted by DiabetesCare.net on June 20, 2011.