Lisdexamfetamine Pregnancy and Breastfeeding Warnings

Brand names: Vyvanse

Medically reviewed by Drugs.com. Last updated on Aug 8, 2023.

Lisdexamfetamine Pregnancy Warnings

Benefit should outweigh risk.

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

Comments:
-The active metabolite of this drug, dexamphetamine, crosses the placenta.
-Premature delivery, low birth weight, and other adverse pregnancy outcomes have been seen in infants born to mothers dependent on amphetamines.
-Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.

There are no controlled data of this drug in human pregnancy, but there are some available data for amphetamines in pregnant women. Two case control studies of over a thousand patients exposed to amphetamines at different gestational ages did not show an increase in congenital abnormalities. Additionally, animal studies have revealed no effects on embryofetal morphological development and survival, nor on fertility.

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.

See references

Lisdexamfetamine Breastfeeding Warnings

-Blood levels of dextroamphetamine 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 of dextroamphetamine had no adverse effects and showed normal progress with 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 produced a sustained suppression of serum prolactin by 40%.

Use should be avoided during breastfeeding.

Excreted into human milk: Yes

Comments:
-This drug is a prodrug of dextroamphetamine. The effect of dextroamphetamine 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

Further information

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