Alerts
Iron dextran injection (Dexferrum) – Black Box Warning for Potentially Fatal Anaphylactic Reaction
October 20, 2009
American Reagent and FDA added new information to the labeling for iron dextran injection explaining the risk of anaphylactic reaction following parenteral administration. Anaphylactic-type reactions, including death, have been reported following the administration of iron dextran injection. In some cases, fatal reactions occurred after the patient tolerated the test dose. The risk of anaphylactic-like reactions is higher in patients with a history of multiple or any drug allergy.
FDA recommends administering a test dose prior to intravenous administration of iron dextran. Additionally, personnel trained in recognizing the signs and symptoms of anaphylactic shock and resuscitation equipment must be present during the administration of the test and therapeutic doses. Administer the therapeutic dose if no signs and symptoms of anaphylactic-like reactions occurred. Monitor patients for the signs and symptoms of anaphylactic-type reactions during the administration of both the test dose and therapeutic dose of iron dextran injection.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm - Information for Healthcare Professionals:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM186900.pdf - Product Information:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf
Updated
October 20, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
