openFDA
Cure8 regulatory brief
Why This Matters
The FDA label update clarifies safety risks and monitoring for TYSABRI (natalizumab), a drug used in Crohn’s disease and MS, including strong warnings about PML and other serious adverse effects that affect treatment decisions.
Patients on or considering natalizumab should be aware of REMS requirements and recommended monitoring.
Who Should Pay Attention
Adult Crohn’s disease patients, patients with MS, clinicians prescribing biologics, pregnant patients exposed to natalizumab, patients on combination immunosuppression.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
TYSABRI (natalizumab) is an anti-integrin biologic approved for Crohn’s disease (induction and maintenance) and multiple sclerosis; the label emphasizes the risk of progressive multifocal leukoencephalopathy (PML) and states TYSABRI is available only through the TOUCH® REMS program.
The label lists risk factors for PML (anti‑JCV antibody status, longer duration of therapy, prior immunosuppressant use) and recommends immediate withholding of dosing and diagnostic steps (gadolinium-enhanced brain MRI and, when indicated, CSF JC virus testing) if PML is suspected.
The label also warns about serious herpes infections, hepatotoxicity, hypersensitivity, immunosuppression/infections, hematologic abnormalities including thrombocytopenia, and notes monitoring recommendations.
It states TYSABRI should not be used with immunosuppressants or TNF‑α inhibitors in Crohn’s disease, and includes guidance on neonatal blood counts after in utero exposure.
Keep In Mind
This is a regulatory drug-label (DailyMed) entry summarizing approved indications, boxed warnings, and monitoring/REMS requirements. It should be read as label language; consult a clinician for personal treatment choices.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
PublisherU.S. Food and Drug Administration
SponsorBiogen Inc.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedOct 9, 2026, 12:00 AM
Content availableRegulatory record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
DailyMed label update for SIMPONI
This label update affects people with IBD because golimumab (SIMPONI) is an approved anti‑TNF treatment for ulcerative colitis and the label includes safety changes and pediatric dosing information that could affect...
DailyMed label update for RINVOQ
A new DailyMed label update for RINVOQ (upadacitinib) outlines FDA-approved uses that include Crohn’s disease and ulcerative colitis and highlights important safety warnings relevant to people with IBD. Patients and...
ABRILADA FDA label update (2026-06-18)
This FDA label update adds or confirms ABRILADA (an adalimumab product) as an approved TNF-blocker option for Crohn’s disease (including children ≥6) and ulcerative colitis (adults). It emphasizes infection and...