AMAG Pharmaceuticals announced that the label for Feraheme (ferumoxytol for intravenous injection) has been updated to include bolded warnings and precautions describing serious post-marketing events. Reported events include life-threatening hypersensitivity reactions and clinically significant hypotension. A new section, entitled Adverse Reactions from Post-Marketing Spontaneous Reports, has been added to the Feraheme labeling. Additionally, the observation period following Feraheme administration has been increased from 30 minutes to 60 minutes to observe patients for signs and symptoms of hypersensitivity.
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