FDA Label Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses

Basic Details
Friday, September 11, 2020
Communication Type
Labeling Change
FDA Center
Medical Product
Feraheme (ferumoxytol)
Infed (iron dextran)
Injectafer (ferric carboxymaltose)
Monoferric (ferric derisomaltose)
Venofer (iron sucrose)
Health Outcome(s)
exposure in pregnancy

This analysis characterized the frequency of IV iron utilization by week relative to live birth and stillbirth deliveries. Information from this analysis contributed to a class-wide labeling update for parenteral iron products to add new safety information to the Use in Specific Populations, Pregnancy section of the label. This update describes the risk of severe adverse reactions to pregnant women and their fetus.