2009-11-04

The Food and Drug Administration (FDA) and American Regent are notifying health-care professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to include the following new information:

• 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.

Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare professional letter and the revised prescribing information.

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