The FDA has issued a significant label revision for Liraglutide, effective 2025-10-16, by adding a boxed warning. This warning highlights the risk of thyroid C-cell tumors, a concern identified in preclinical studies.
Background
Liraglutide is an active pharmaceutical ingredient found in several products. These include Victoza, Saxenda, and the combination product Xultophy 100/3.6, which also contains insulin degludec. Other related formulations listed include insulin degludec and liraglutide.
What this means
The addition of a boxed warning is the most serious type of warning issued by the FDA and is intended to draw attention to serious or life-threatening risks. For Liraglutide, this warning specifically states there is a "RISK OF THYROID C-CELL TUMORS." It details that Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. The label further indicates that it is unknown whether Liraglutide injection c. This critical safety information requires healthcare professionals to carefully consider the potential risks when prescribing Liraglutide and to counsel patients appropriately.
Source
The information regarding this FDA label revision was obtained from the FDA, with the updated label effective 2025-10-16. The source document is available on the dailymed.nlm.nih.gov website.