-This drug has been shown to be teratogenic in animal studies at doses 6 times higher than therapeutic human doses. Skeletal defects, cleft palates and fetal toxicity (resorptions) have been reported. There are no controlled data in human pregnancy.
-Although normal outcomes have been reported, characteristic congenital cutis laxa and associated birth defects have been reported in infants born of mothers who received this drug during pregnancy.
-It has been reported that a woman with rheumatoid arthritis treated with less than 1 gram a day of this drug during pregnancy gave birth (cesarean delivery) to an infant with growth retardation, flattened face with broad nasal bridge, low set ears, short neck with loose skin folds, and unusually lax body skin.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

US: Contraindicated
AU, UK:
This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments:
-This drug can cause cutis laxa in the human fetus when administered to a pregnant woman.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
-This drug should not be administered to rheumatoid arthritis patients who are pregnant.
-Continued treatment with this drug throughout pregnancy protects the mother against relapse of Wilson's disease, and discontinuation of therapy has deleterious effects on the mother.
-If this drug is administered during pregnancy to patients with Wilson's disease, it is recommended that the daily dosage be limited to 1 gram. If a cesarean section is planned, the daily dosage should be limited to 250 mg during the last 6 weeks of pregnancy and postoperatively until wound healing is complete.
-If possible, this drug should not be given during pregnancy to women with cystinuria. There are reports of women with cystinuria on therapy who gave birth to infants with generalized connective tissue defects who died following abdominal surgery. If stones continue to form in these patients, the benefits of therapy to the mother should be evaluated against the risk to the fetus.

See references

US: Contraindicated
AU, UK: 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: Data not available
Excreted into animal milk: Data not available

Comment:
-Copper and zinc levels in breastmilk are reduced in patients taking this drug. The implications for infants of this effect are not known.

-This drug has been used with apparent safety during nursing of 3 infants. In infants who breastfeed infrequently, taking the drug right after nursing and waiting 4 to 6 hours before nursing again should minimize the amount of the drug in breastmilk.

See references