Subcutaneous administration to pregnant mice during organogenesis has shown an increased incidence of delayed skeletal ossification and decreased fetal body weight at the 2 highest doses tested and an increase in embryofetal death at the highest dose. In rabbits, an increase in embryofetal death occurred at the 2 highest doses tested. In rats, increased embryofetal death was observed at all doses, an effect believed to be due to the prolactin-lowering effect of the drug. 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.

Not recommended

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

Risk Summary: There are no adequate data on developmental risk associated with human use; animal studies have shown effects on embryofetal development at doses similar to or lower than those used clinically.

Comments: Use of adequate methods of contraception should be encouraged.

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Subcutaneous administration to rats throughout pregnancy and lactation revealed impaired growth and development during lactation and long-term neurobehavioral abnormalities in the offspring at the highest dose tested. When offspring were mated, growth, and survival of the next generation were adversely affected. In humans, inhibition of lactation may occur because this drug decreases prolactin secretion.

Not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown; however, since this drug decreases prolactin secretion in humans, inhibition of lactation is expected.

See references