Avonex Linked With Psychiatric Disorders, Other Adverse Effects

March 14, 2003

March 14, 2003 — Biogen, in collaboration with the U.S. Food and Drug Administration (FDA), has revised the safety labeling for its multiple sclerosis drug interferon beta-1a (Avonex) to reflect reports of psychiatric, hematologic, autoimmune, and hepatic disorders associated with use of the drug.

According to a notice posted today on the FDA's MedWatch Web site, the new labeling describes "[p]ost-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."

According to a Biogen letter to healthcare professionals, dated March 7, additional safety labeling changes include a complete revision of the Patient Information section, which is now a Medication Guide that describes the new safety warnings and information on self-administration of the drug

Healthcare professionals may report any serious adverse events possibly associated with the use of interferon beta-1a to Biogen at 1-800-456-2255 or to the FDA's MedWatch reporting system by phone (1-800-FDA-1088), facsimile (1-800-FDA-1078), or the MedWatch Web site at https://www.fda.gov/medwatch/how.htm or mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD


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