Pramipexole Pregnancy and Breastfeeding Warnings
Pramipexole Pregnancy Warnings
Based on animal data, this drug may cause fetal harm. Embryotoxicity was observed in rats at maternotoxic doses. This finding was thought to be due to the prolactin-lowering effect of the drug; prolactin is necessary for implantation and maintenance of early pregnancy in rats, but not humans or rabbits. Teratogenicity was not observed in rats and rabbits, however due to the high incidence of total resorption of the embryos in rats, it is believed this effect has not been adequately evaluated. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C
Pramipexole Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: This drug inhibits prolactin secretion and could potentially 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 suppresses serum prolactin, it may interfere with breastfeeding. Use of this drug is not recommended while breastfeeding and a decision should be made to discontinue breastfeeding or discontinue this drug, taking into account the importance of the drug to the mother.
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