Amphetamine / dextroamphetamine Pregnancy and Breastfeeding Warnings

Brand names: Adderall, Adderall XR, Mydayis

Medically reviewed by Drugs.com. Last updated on Sep 13, 2024.

Amphetamine / dextroamphetamine Pregnancy Warnings

Use is recommended during pregnancy only if the potential benefit justifies the possible risk to the fetus.

US FDA pregnancy category: C

Comments: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight, and may experience withdrawal symptoms (e.g., dysphoria, agitation and significant lassitude).

In the enantiomer ratio present in this drug, some animal studies show amphetamine had no apparent effects on embryofetal morphological development or survival while other data offspring effects (e.g., decreased survival, increased locomotor activity, reduced body weight) in addition to maternal effects (e.g., hyperactivity and decreased weight gain). Animal studies also reveal long-term neurochemical and behavioral effects with exposure to amphetamine (d- or d-,l-isomers) at doses similar to those used clinically. There has been one report of severe congenital bony deformity, trachea-esophageal fistula, and anal atresia (vater association) in an infant whose mother took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. There are no reported effects on fertility.

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.

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Amphetamine / dextroamphetamine Breastfeeding Warnings

Breastfeeding is not recommended during treatment.

Excreted into human milk: Yes

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

Level 2:
-The urinary excretion in 2 breastfed infants whose mothers took amphetamine 20 to 35 mg/day ranged from 0.1% to 2.1% of the mothers' excretion; these infants showed no signs of abnormal development.
-Dextroamphetamine blood levels 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/day dextroamphetamine had normal progress, no adverse effects, and weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, dextroamphetamine 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 of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.

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Further information

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