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 (bladder cancer) as AstraZeneca.
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 · Bladder Cancer
- Sub-indication
- Bladder Cancer
Related signal: Imfinzi + EV shows significant survival benefits in muscle-invasive bladder cancer