Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Reports of anaphylactic-type reactions, including fatalities, following the administration of Dexferrum (iron dextran injection, USP) used to treat anemia or “iron-poor” blood in people who are unable to take oral iron medication, has spurred American Regent, Inc., makers of the drug, to modify the medicine’s black box warning, and the Food and Drug Administration (FDA) to issue a warning to hematological health care professionals and hospital risk managers.

The boxed warning for Dexferrum includes precautionary measures to mitigate the risk of anaphylactic-type reactions. It also clarifies the differences in the chemical characteristics and clinical effects of iron dextran preparations to minimize potential confusion between available products on formulary.

Modifications to the boxed warning include:

• A recommended test dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow, a full therapeutic dose can be given.
• Observation for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.
• A warning that fatal reactions have occurred following the test dose and have also occurred when the test dose was tolerated.
• A note that patients with a history of drug allergies may be at greater risk of anaphylactic-type reactions.

Health care professionals are advised to take these necessary precautions following the parenteral administration of iron dextran injection:

• Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Dexferrum administration.
• Administer a test of Dexferrum dose prior to the first therapeutic dose.
• During all Dexferrum administrations, observe for signs or symptoms of anaphylactic-type reactions.
• Use Dexferrum only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.

Prescribers of the medication are encouraged to review the full prescribing information and discuss it with their patients in order to make the appropriate treatment decisions based on the benefit-risk profile of iron dextran products.

This entry was posted on Tuesday, October 20th, 2009 at 7:35 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.