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U.S. Department of Health and Human Services

Safety

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DexFerrum (iron dextran) 50 mg/mL injection

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

 

Summary View

 

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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