Test Dose Needed Before Iron Dextran Therapy

Cheryl A. Thompson

BETHESDA, MD 16 October 2009—Labeling for the injectable iron dextran products Dexferrum (PDF) and INFeD (PDF) now contain a boxed warning instructing clinicians to administer a test dose before the first therapeutic dose.

The boxed warning was added to both products' labeling during the summer. American Regent Inc., marketer of Dexferrum, recently informed health care professionals by means of a letter (PDF), which FDA circulated today through its MedWatch program.

Patients have died of anaphylactic-type reactions after receiving an injection of an iron dextran product, the boxed warning states.

These deaths have occurred after a test dose and even in situations when the test dose did not elicit signs or symptoms of an anaphylactic-type reaction.

The boxed warning also states that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions need to be readily available during administration of the drug.

An external review (PDF) of 2001–03 MedWatch data on iron-related adverse events found that 16 people had had an anaphylactoid reaction to an iron dextran product. Seven people who had iron-related adverse events died, although not necessarily of an anaphylactoid reaction.

INFeD is marketed by Watson Pharmaceuticals Inc.