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FDA Medwatch Alert: Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed
Posted 2 Apr 2015 by Drugs.com
ISSUE: FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). FDA changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of Feraheme’s approval in 2009, this risk was described in the Warnings and Precautions section of the drug label. Since then, serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures (see Drug Safety Communication/Data Summary). FDA eval ... Read more