Los Angles County
MARCH 2003
Department of Health Services
LAC & USC Healthcare Network
Department of Pharmacy
Drug Information Center

DRUG BULLETIN

NEW WARNINGS AND PRECAUTIONS ABOUT INTERFERON
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 was added.