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FDA notification of labelling change for iron dextran injection (Dexferrum®) following reports of anaphylaxis

Source: FDA

Date published: 19/10/2009 15:33

Summary
by: Yuet Wan

The FDA has issued a notification about a labelling change for iron dextran injection (Dexferrum®) following reports of anaphylactic-type reactions, including fatalities after the parenteral administration of iron dextran injection (Dexferrum®). 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 drug administration. Fatal reactions have even occurred even when 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. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.

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