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Drug Safety-related Labeling Changes (SrLC)

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INFED (NDA-017441)

(IRON DEXTRAN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/20/2021 (SUPPL-179)

Approved Drug Label (PDF)

Other

(Physicians Labeling Rule (PLR) conversion; please refer to label)

09/11/2020 (SUPPL-178)

Approved Drug Label (PDF)

5 Warnings and Precautions

PRECAUTIONS

Pregnancy

Newly added information:

Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as INFED) which may cause fetal bradycardia, especially during the second and third trimester.