Synagis labeling adds anaphylaxis warning
Executive Summary
MedImmune revises Synagis (palivizumab) labeling to include incidences of anaphylaxis in the warnings section. "Very rare cases of anaphylaxis (<1 case per 100,000 patients) have been reported following re-exposure to Synagis," revised labeling for the respiratory syncytial virus humanized monoclonal antibody says. Previous labeling included a theoretical risk statement regarding anaphylaxis. Labeling now includes data for patient exposure beyond five doses in a single RSV season, stating "adverse events after a sixth or greater dose of Synagis are similar in character and frequency to those after the initial five doses." MedImmune sent a "Dear Healthcare Professional" letter regarding the changes Nov. 26...
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