Fatalities Associated with Dextran Iron Injection

American Regent and the Food and Drug Administration have issued a notification to healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.

The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.

Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions.

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Published on Oct-16-09