The label for Tofacitinib (Xeljanz, Xeljanz XR) now includes a boxed warning, effective 2026-06-08. This significant label revision highlights serious risks associated with the drug, specifically addressing serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
What this means
The addition of a boxed warning to the Tofacitinib label underscores critical safety considerations for healthcare providers and patients. Boxed warnings are the strongest warnings the FDA requires, indicating that the drug carries significant risks that may lead to serious injury or death. Clinicians prescribing Tofacitinib must now carefully consider the increased risks of serious infections, higher mortality, potential for malignancy, occurrence of major adverse cardiovascular events, and risk of thrombosis when evaluating patient suitability and monitoring treatment.
Source
This information regarding the label revision for Tofacitinib was sourced from the FDA, detailing a boxed warning effective 2026-06-08, and is accessible via dailymed.nlm.nih.gov.