Fosrenol Pregnancy Warnings
Doses up to 3 times the maximum recommended human dose (MRHD) to pregnant rats during organogenesis did not show fetal harm while administration of 5 times the MRHD to pregnant rabbits was associated with increased postimplantation loss, reduced fetal weights, and delayed fetal ossification. In long-term animal studies, drug deposits have been observed in developing bone, including growth plate. The significance of this is not known. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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 not recommended
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: Available data in pregnant women is insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; this drug has been observed in the developing bone of juvenile animals in long-term animal studies although the significance of this is unknown.
Comments: Non-lanthanum containing phosphate binders are recommended in pregnant women.
See references
Fosrenol Breastfeeding Warnings
Not recommended
Excreted into human milk: Yes
Excreted into animal milk: Unknown
Comments: A non-lanthanum containing phosphate binder should be used in lactating women.
There is some evidence that lanthanum may be excreted in breast milk. Animal studies have shown lanthanum deposits in developing bone of juvenile animals although long term studies have not shown growth abnormalities. Offspring of rats receiving oral doses of lanthanum carbonate 2000 mg/kg/day showed post-natal developmental delays.
See references
