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Reports of anaphylactic-type reactions lead to revised boxed warning for iron dextran
The FDA and American Regent today announced a notice to health care professionals that anaphylactic-type reactions, including fatalities, have been reported after administration of iron dextran injection.
The boxed warning was modified to recommend administering a test dose before the first therapeutic dose and to observe patients for signs or symptoms of anaphylactic-type reactions during administration of iron dextran injection (Dexferrum, Luitpold Pharmaceuticals Inc.). The reports to the FDA have included fatal reactions even in situations where the test dose was tolerated.
The FDA warned that patients with a history of drug allergy or multiple drug allergies may be at increased risk for anaphylactic-type reactions. The agency recommended that resuscitation equipment and personnel trained to detect and treat anaphylactic-type reactions be available during administration of iron dextran injection.
In a letter to health care professionals, dated Sept. 25, 2009, the FDA also informed them of added statements to the boxed warning that clarify the differences in chemical characteristics and clinical effects of iron dextran preparations to minimize confusion between the available products on formulary.
The warnings section for anaphylactic-type reactions has also been updated to elevate the precaution about potential increased risks with concomitant use of angiotensin-converting enzyme inhibitor drugs.
The FDA and American Regent encouraged prescribers of iron dextran injection to review the full prescribing information and discuss with patients to make the appropriate treatment decisions based on the benefit-risk profile with the product. The revised full prescribing information is available on American Regent’s website at www.americanregent.com.
Health care professionals should report all serious adverse events suspected to be associated with use of Dexferrum to Luitpold Pharmaceuticals Inc., 800 Adams Avenue, First Floor, Valley Forge, Pa., 19403 or by phone at 1-800-734-9236.
