Label Changes for:
INFeD (iron dextran) 50 mg elemental iron/mL injection
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
Warning: Risk for anaphylactic-type reactions
- Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection...
- 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 iron dextran.