MedImmune has revised the labeling for its drug palivizumab (Synagis) to provide clarification on the risk of anaphylaxis, according to an alert from the U.S. Food and Drug Administration (FDA) last week. The labeling was also revised to reflect that adverse events after a sixth or greater dose of palivizumab are similar in character and frequency to those after the initial five doses.
The decision to revise the drug’s labeling was based on worldwide postmarketing studies in which very rare cases of anaphylaxis were reported after re-exposure to palivizumab. Rare severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to palivizumab
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