FDA Recommends Test Doses to Reduce Risk of Dexferrum Allergic Reactions

Doctors should give anemic patients test doses of the iron deficiency treatment drug Dexferrum, to check for potentially deadly allergic reactions, according to a new labeling change the FDA announced Friday.

The label recommends that doctors test patients with small does of Dexferrum, an iron dextran injection, due to the possibility of anaphylactic shock, which can be fatal if not treated quickly. The new information will be added to an existing “black box” warning about the potential Dexferrum side effects.

Manufactured by American Regent, Dexferrum was first approved by the FDA in 1996. It is used to treat iron deficiency and anemia in patients for whom oral iron therapy is ineffective or not an option.

American Regent and FDA warned healthcare professionals that resuscitation equipment and trained personnel should be on hand whenever iron dextran injections are administered. Neither the FDA nor American Regent reported the number of fatalities which had occurred due to Dexferrum anaphylactic shock, however they did warn that fatal reactions have occurred even after test doses were given and appeared to be tolerated.

It is unclear whether INFeD, another iron dextran medication, is also affected by the labeling change.