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Important Boxed Warning Change for Dexferrum
American Regent and FDA are issuing a boxed warning change for Dexferrum, an iron dextran injection. The new warning on the Dexferrum label notifies health care professionals of anaphylactic-type reactions and fatalities with this drug when administered parenterally. A test dose prior to the first therapeutic dose, and observing patient for signs or symptoms of anaphylactic-type reactions, is recommended. Fatal reactions have been reported following a test dose of Dexferrum, even after the test dose was tolerated. Patients with other allergies may be at an increased risk. Resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions should be available during Dexferrum administration. For more information: Read the complete MedWatch 2009 Safety Summary, including links to the Dear Healthcare professional letter and the revised prescribing information.
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