The Food and Drug Administration is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol).
The agency has changed the prescribing instructions and approved a boxed warning, its strongest type of warning, regarding these serious risks. The FDA also said March 30 it has added a new contraindication against using Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.
According to the website of Amag Pharmaceuticals, Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). ...
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