Los Angles County
Department of Health Services
LAC & USC Healthcare Network
Department of Pharmacy
Drug Information Center
NEW WARNINGS AND PRECAUTIONS
Audience: Neurologists and other healthcare
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
Post-marketing reports of depression, suicidal ideation
of new or worsening of pre-existing psychiatric disorders,
psychosis, and reports of anaphylaxis, pancytopenia, thrombocytopenia,
autoimmune disorders of multiple target organs, and hepatic
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.