FDAsafety guidance72% confidence
Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (colorectal cancer) as Takeda.
Regulatory Analysis
FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
Supporting Context
- Therapeutic area
- Oncology · Colorectal Cancer
- Sub-indication
- Colorectal Cancer
Related signal: Fruquintinib Study in Metastatic Colorectal Cancer Patients in Poland