Regulatory Determination / Use
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.
Result(s) (1)Intravenous (IV) Iron Utilization Among Pregnant Women
Regulatory Link(s) (1)Drug Safety-related Labeling Changes