Label Changes for:

DexFerrum (iron dextran) 50 mg/mL injection

August 2009

Changes have been made to the BOXED WARNING and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

BOXED WARNING

Warning: Risk for anaphylactic-type reactions
  • Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection...

PRECAUTIONS

  • Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administer a test dose prior to the first administration of Dexferrum.
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