Dexferrum (iron dextran injection): Risk of anaphylactic-type reactions, including fatalities, following parenteral administration of iron dextran

Dexferrum (iron dextran injection): Risk of anaphylactic-type reactions, including fatalities, following parenteral administration of iron dextran

Dexferrum (iron dextran injection) - Labeling change
Audience: Hematological healthcare professionals, hospital risk managers
American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. 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 administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran 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. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.
Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare professional letter and the revised prescribing information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm

Dexferrum (iron dextran injection) - labeling change
Audience: Hematological healthcare professionals, hospital risk managers

[Posted 10/16/2009] American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. 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 administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran 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. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.

[09/25/2009 - Dear Healthcare Professional Letter - American Regent]
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM186900.pdf

[08/2009 - Prescribing Information - American Regent]
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf