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U.S. Department of Health and Human Services

Safety

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Humira (adalimumab) Nov 2004

Audience: Rheumatologists and other healthcare professionals

FDA and Abbott Pharmaceuticals notified healthcare professionals of revisions to the WARNINGS section of the prescribing information, indicated for the treatment of rheumatoid arthritis. These warnings include serious infections with the combined use of Humira (adalimumab) and anakinra, hypersensitivity reactions, including anaphylaxis, and hematologic events, including pancytopenia and aplastic anemia.

[November 05, 2004 - Letter - Abbott]
[July, 2004 - Revised Label - Abbott]