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FDA Expands Boxed Warning on Iron Dextran Injections
The boxed warning on risk for anaphylactic reactions with Dexferrum (iron dextran) injections has been updated with guidance on giving a test dose before therapeutic dosing and watching for anaphylactic reactions during administration, the FDA has announced.
Fatal reactions have occurred after the test dose and with the therapeutic dose even after testing was tolerated, according to the manufacturer. Patients with drug allergies may be at increased risk.
The manufacturer recommends that resuscitation equipment and trained personnel be "readily available" when Dexferrum is given.
LINK(S):
FDA alert (Free)
Updated Dexferrum label (Free PDF)
Manufacturer letter to healthcare professionals (Free PDF)
Published in Physician's First Watch October 19, 2009
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