Benefit should outweigh risk; some authorities consider use contraindicated

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Based on animal data, this drug may cause fetal harm; animal studies have revealed evidence of embryotoxicity at clinically relevant doses.

Comments:
-Women of child-bearing potential should consider use of highly effective contraception during treatment, and for 5 days after their last dose

This drug has not been tested in animals using currently recommended methodology, but there are published reports of developmental toxicity in animals. In pregnant rats given this drug during organogenesis (gestation days 7 to 12), embryolethality and reduced fetal body weight occurred at a dose that was associated with maternal toxicity. The no-effect dose for developmental toxicity in mice has been reported as less than the recommended human dose based on body surface area (mg/m2). Evaluation of parturition, lactation, and post-natal development in a limited number of litters from mouse and rat studies have shown reductions in live litter size and pup birthweight at mg/kg doses similar to the maximum recommended human dose. There are no controlled data in human pregnancy.

This drug impaired fertility in both male and female rats when administered at a dose equivalent to the maximum recommended human dose on a mg/m2 basis.

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.

See references

This drug is excreted in human milk, but the amount has not been quantified. This drug is a dopamine agonist and clinical studies in patients taking 100 mg 2 or 3 times a day with neuroleptic medications have demonstrated reduced serum prolactin levels and decreased galactorrhea. Data on the effect this drug on a mother's milk supply is lacking. Undesirable effects have been reported in breastfed infants. 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 on the breastfed infant from this drug or from the underlying maternal condition.

Not recommended

Excreted into human milk: Yes

Comment:
-It is generally best to avoid this drug because of its potential negative effects on lactation.

See references