Ferriprox Use In Pregnancy & Lactation

Use in pregnancy: FC tab: There is no adequate information on the use of deferiprone in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: FC tab under Actions). The potential risk for human is unknown.
Women of childbearing potential must be advised to avoid pregnancy due to the clastogenic and teratogenic properties of Ferriprox. These women should be counseled to take contraceptive measure and must be advised to immediately stop taking deferiprone if they become pregnant or plan to become pregnant.
Oral Solution: Pregnancy Category D (Precautions and Pharmacology: Toxicology: Oral Solution under Actions).
Risk Summary: Based on evidence of genotoxicity and developmental toxicity in animal studies, FERRIPROX can cause fetal harm when administered to a pregnant woman. In animal studies, administration of deferiprone during the period of organogenesis resulted in embryofetal death and malformations at doses lower than equivalent human clinical doses. There are no studies in pregnant women, and available human data are limited. If FERRIPROX is used during pregnancy or if the patient becomes pregnant while taking FERRIPROX, the patient should be apprised of the potential hazard to the fetus.
Animal Data: Skeletal and soft tissue malformations occurred in offspring of rats and rabbits that received deferiprone orally during organogenesis at the lowest doses tested (25 mg/kg per day in rats; 10 mg/kg per day in rabbits). These doses were equivalent to 3% to 4% of the maximum recommended human dose (MRHD) based on body surface area. No maternal toxicity was evident at these doses.
Embryofetal lethality and maternal toxicity occurred in pregnant rabbits given 100 mg/kg/day deferiprone orally during the period of organogenesis. This dose is equivalent to 32% of the MRHD based on body surface area.
Use in lactation: FC tab: It is not known whether deferiprone is excreted in human milk. No prenatal and postnatal reproductive studies have been conducted in animals. Deferiprone should not be used by nursing mothers. If treatment is unavoidable, breastfeeding must be stopped.
Oral Solution: It is not known whether deferiprone is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from FERRIPROX, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.