Interferon labeling
Executive Summary
Manufacturers of alpha and beta interferon products are requested to submit revised labeling with a black box warning in a Feb. 26 letter from the Center for Biologics Evaluation & Research. The revised labeling should indicate the potential for life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders, CBER says. The black box will be similar to the warning found in labeling for Schering-Plough's PEG-Intron (1"The Pink Sheet" Jan. 29, p. 16)