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Dexferrum Boxed Warning Modified for Anaphylactic-Type Reactions

Oct 16, 2009 | Parker Waichman LLP

The Boxed Warning for Dexferrum (iron dextran injection, UPS) has been updated to emphasize the warning about anaphylactic-type reactions that have occurred following parenteral administration.  According to the Food & Drug Administration (FDA), some of these reactions have been fatal.

A "Dear Health Care Provider" letter issued by American Regent said the following recommendations were added to the Boxed Warning of Dexferrum:

  • To administer a test dose prior to the first therapeutic dose; if no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic dose.
  • To observe for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.
  • To make clear that fatal reactions have occurred following the test dose and have also occurred when the test dose was tolerated.
  • To note that patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions


According to the FDA, fatal reactions have followed the test dose of Dexferrum 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. The FDA recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.

Dexferrum is an intravenous iron preparation used in the treatment of iron deficiency anemia or anemia caused by blood loss when oral iron cannot be tolerated.  Iron is important for many functions in the body, especially for the transport of oxygen in the blood.  Dexferrum is given by injection, usually once a day.


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