Dexferrum Labeling Changed to Warn of Severe Allergic Reactions

The boxed labeling for the iron-deficiency anemia drug Dexferrum has been updated to warn about the risks of deadly anaphylactic-type allergic reactions in some patients given the iron dextran injections.

The Food and Drug Administration and the drug’s maker, American Regent, also recently sent a letter to doctors and other healthcare professionals informing them of the risks and advising them about changes in how the drug should be administered to reduce the risk of injury and death to patients.

Dexferrum is an intravenous iron preparation used in the treatment of iron deficiency anemia or anemia caused by blood loss when oral iron cannot be tolerated. It replenishes body iron stores in patients with iron deficiency.

Doctors are being advised to administer a test dose of the drug and watch for signs or symptoms of anaphylactic-type shock in patients before proceeding with full doses. However, some patients have died and suffered serious complications even after initial test doses were tolerated, the FDA cautioned.

Patients with a history of drug allergies may be at greater risks of developing anaphylactic-type reactions to Dexferrum injections, the FDA said.

The FDA also is recommending that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be on hand during Dexferrum administration to intervene as necessary in the event of allergic shock.

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