This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: A
US FDA pregnancy category: Not assigned.

Risk Summary: Malformative risk with use of this drug in pregnant women is unlikely.

Comments:
-Use during the first and third trimesters should be avoided when possible.
-Monitoring for extrapyramidal syndrome and methemoglobinemia is recommended for neonates exposed during the third trimester and/or delivery.
-After delivery, mothers are at a relatively high risk for postpartum depression, and this drug can cause depression as a side effect. Therefore, therapy should probably be avoided in women with a history of major depression and not used for prolonged periods in any mother during this time of high susceptibility.

Human data (greater than 1000 outcomes) do not indicate fetotoxicity or malformative toxicity associated with therapy. Use at the end of pregnancy may result in extrapyramidal syndrome of the neonate.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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

Variable amounts are excreted in breast milk, with some infants receiving doses that achieve pharmacologically active serum levels, elevated serum prolactin and possible gastrointestinal side effects. This drug is used as a galactagogue, but its clinical value in increasing milk supply is questionable.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Nursing infants should be monitored for signs/symptoms of extrapyramidal symptoms and methemoglobinemia.
-Due to the potential for neural development defects, the WHO recommends that this drug should be avoided if possible.
-The American Academy of Pediatrics considers this drug an agent for which the effect on a nursing infant is unknown but may be of concern as this drug is a dopaminergic blocker.

See references