Inbrija Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: Data are inadequate to inform a developmental risk in pregnant women; in animals, carbidopa/levodopa has been shown to be developmentally toxic (including teratogenic effects).
Based on animal data, this drug may cause fetal harm. Administration of carbidopa/levodopa to pregnant rabbits through organogenesis caused visceral and skeletal malformations. These effects were not observed in studies with pregnant mice. In rats, a decrease in the number of live pups occurred with carbidopa/levodopa administration during organogenesis. 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.
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Inbrija Breastfeeding Warnings
There is limited data on this drug's effect on milk production in lactating women. There are several studies showing it may decrease serum prolactin during lactation, although the prolactin level in a mother with established lactation may not affect her ability to breastfeed. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
Benefit should outweigh risk
Excreted into human milk: Yes
Comment: The effects in the nursing infant are unknown.
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