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AMAG's Feraheme modifies its labeling, but FDA does not require a black box warning. |
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Zacks: AMAG has been instructed to describe events like life-threatening hypersensitivity reactions and clinically significant hypotension that have been reported following administration of Feraheme in the post-marketing environment. These events will be described as bolded warnings and precautions in the updated label. The company will also be required to insert a new section to the label entitled Adverse Reactions from Post-Marketing Spontaneous Reports. Finally, the label will also instruct health care providers to observe patients for an additional 30 minutes for signs and symptoms of hypersensitivity following administration of Feraheme. Earlier, patients were observed for 30 minutes.
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