Although there are no controlled data in human pregnancy, the use of amphetamine drugs during early pregnancy has been associated with an increased risk of congenital malformations. Additionally, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (Vater association) in an infant whose mother took this drug with lovastatin during the first trimester of pregnancy.

Some animal studies have revealed evidence of embryotoxicity, teratogenicity, and reproductive toxicity. Animal data also showed developmental delays, behavioral sensitization, and increased motor activity in animal offspring due to prenatal exposures at dose levels comparable to human therapeutic dose levels.

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.

UK: Use is contraindicated during pregnancy.
AU and US: Use is not recommended during pregnancy.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-Infants born to mothers dependent on amphetamine drugs have an increased risk of premature delivery and low birth weight, and may experience withdrawal symptoms including dysphoria, agitation, hyperexcitabilitiy, and significant lassitude.
-Females of reproductive potential should be advised to avoid pregnancy during treatment.

See references

-Blood levels of this drug in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg per day of this drug had no adverse effects and showed normal progress with weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, this drug reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose produced a sustained suppression of serum prolactin by 40%.

UK: Use is contraindicated during breastfeeding.
AU and US: Breastfeeding is not recommended during treatment.

Excreted into human milk: Yes

Comments:
-The effect of this drug in milk on the neurological development of a breastfed infant has not been well studied.
-Large dosages of this drug might interfere with milk production, especially in women whose lactation is not well established.

See references