Mirapex er Pregnancy Warnings
Embryotoxicity has been observed in rats at maternotoxic doses. This high incidence of total resorption of embryos in rats is believed to be due to the prolactin-lowering effects of the drug. Unlike humans or rabbits, prolactin is necessary for implantation and maintenance of early pregnancy in rats. In rabbits, no adverse developmental effects were observed. Teratogenicity in rats has not been adequately evaluated due to the high incidence of total resorption of the embryos. Postnatal growth was inhibited in the offspring of rats given this drug during the latter part of pregnancy and throughout lactation. There are no adequate and well controlled studies in pregnant women.
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.
Benefit should outweigh risk
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk summary: There are no adequate data on the developmental risks associated with use of this drug in pregnant women; based on animal data, this drug may cause fetal harm.
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Mirapex er Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments: This drug inhibits prolactin secretion and therefore may inhibit lactation.
A single-dose, radio-labeled study in rats showed this drug is present in rat milk at concentrations 3 to 6 times higher than plasma. There is no information on use in human nursing mothers. As this drug lowers serum prolactin, it may interfere with breastfeeding, especially in a new mother. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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