Ferriprox Pregnancy Warnings
Animal studies using oral doses 33 to 49% of the maximum recommended human dose (MRHD) showed structural abnormalities (external, visceral and skeletal malformation including cranial malformations, limb malrotation, cleft palate, anal atresia, internal hydrocephaly, anophthalmia, partially opened eyes, and fused bones), growth alteration, and fetal death in the presence of maternal toxicity. At doses 5 to 13% the MRHD malformations including micrognathia and persistent ductus arterious were seen without maternal toxicity. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk Summary: Based on genotoxicity and developmental toxicity in animal studies, this drug may cause fetal harm when administered during pregnancy.
Comments:
-Pregnancy testing is recommended prior to initiating therapy.
-This drug can cause embryo-fetal harm; females of reproductive potential should use effective contraception during therapy and for at least 6 months after stopping.
-Males with partners of reproductive potential should use effective contraception during therapy and for at least 3 months after stopping.
-If used during pregnancy, or the patient becomes pregnant, apprise the patient of potential harm to the fetus.
-Limited data in pregnant women is insufficient to know this drugs risks of major birth defects or miscarriage.
-Animal studies showed genotoxicity and developmental toxicity at doses lower than the maximum recommended human dose.
See references
