The label for Liraglutide received a new boxed warning on 2026-06-24. This significant update highlights the risk of thyroid C-cell tumors, observed in preclinical studies. The warning indicates that Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors in both male and female rats and mice.
Background
Liraglutide is known by several aliases, including Xultophy 100/3.6, Saxenda, Victoza, insulin degludec and liraglutide, and insulin degludec. This label revision impacts all formulations of the drug.
What this means
The addition of a boxed warning is the strongest safety warning the FDA requires for prescription drugs. For Liraglutide, this warning specifically addresses the "RISK OF THYROID C-CELL TUMORS." The preclinical data indicates that Liraglutide causes these tumors in a dose-dependent and treatment-duration-dependent manner. These findings were observed at clinically relevant exposures in both male and female rats and mice. A key aspect of the warning is the explicit statement that "It is unknown whether liraglutide causes thyroid C-cell tumors in humans," emphasizing the need for healthcare providers and patients to be aware of this potential risk identified in animal models.
Source
This label revision was issued by the FDA on 2026-06-24. The updated label information is available on dailymed.nlm.nih.gov, an official database of drug labeling provided by the National Library of Medicine.