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FDA issues REMS for liraglutide injection
Novo Nordisk announced today the issuance of a letter to health care providers, as required by a Risk Evaluation and Mitigation Strategy, reminding them of important safety information associated with liraglutide injection.
According to the FDA, a recent evaluation showed that some primary care providers are unaware of the serious risks associated with liraglutide (Victoza).
In both male and female rats and mice, liraglutide — at clinically relevant exposures — may cause dose-dependent and treatment-duration-dependent thyroid C-cell tumors. Whether the drug causes these tumors, including medullary thyroid carcinoma, in humans remains unknown. However, clinical trials have demonstrated an association between pancreatitis and liraglutide, according to a press release.
In the statement, the FDA recommends referral to an endocrinologist when thyroid nodules are found in patients during physical examination or neck imaging obtained for other reasons. Patients should also be referred if serum calcitonin is measured and elevated, although the routine monitoring of this marker is of uncertain value in patients treated with the drug.
Patients should be observed carefully for signs of pancreatitis after initiation and dose increases of liraglutide injection. The FDA urges health care providers and patients to report all adverse events and quality problems associated with the drug through the MedWatch Safety Information and Adverse Events Reporting Program.
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