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U.S. Department of Health and Human Services

Safety

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Avonex (Interferon beta-1a) Revisions

Audience: Neurologists and other healthcare professionals

Biogen and FDA revised the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT INFORMATION, and CLINICAL STUDIES sections of the prescribing information to include important new safety information and a patient Medication Guide. Updated safety information includes a cautionary note regarding use in patients with depression and other severe psychiatric symptoms.

Post-marketing reports of depression, suicidal ideation and/or development of new or worsening of pre-existing psychiatric disorders, including psychosis, and reports of anaphylaxis, pancytopenia, thrombocytopenia, autoimmune disorders of multiple target organs, and hepatic injury manifesting itself as elevated serum enzyme levels and hepatitis were added to the labeling.

An FDA-approved Patient Medication Guide, providing important patient safety information and comprehensive instructions for patient self-administration of Avonex, was added.

[March 7, 2003 - Letter - Biogen]