USA. Biogen Idec, in consultation with the United States Food and Drug Administration (US FDA) has written to health-care professionals that post-marketing reports of severe cutaneous or mucocutaneous reactions, some with fatal outcome, have been received for ibritumomab tiuxetan (Zevalin), a radio-immunotherapy approved for the treatment of non-Hodgkin's lymphoma. The product label has been updated with a boxed warning to reflect this information. Health-care professionals are advised that the potential risk of these reactions should be considered when using the ibritumomab tiuxetan (Zevalin) regimen. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the regimen and should receive prompt medical evaluation.

Reference:

'Dear Health-care Professional' letter from Biogen Idec, October 2005 (http://www.fda.gov).