Lisdexamfetamine use while Breastfeeding

Summary of Use during Lactation

Lisdexamfetamine is a prodrug of dextroamphetamine. In dosages prescribed for medical indications, some evidence indicates that dextroamphetamine might not affect nursing infants adversely. The effect of dextroamphetamine in milk on the neurological development of the infant has not been well studied. It is possible that large dosages of dextroamphetamine might interfere with milk production, especially in women whose lactation is not well established. Therapeutic dosages of amphetamine can be used during nursing with monitoring of the infant for irritability, insomnia, and feeding difficulty.[1] Breastfeeding is generally discouraged in mothers who are actively abusing amphetamines.[2-4]

Drug Levels

Maternal Levels. Four mothers averaging 5.5 months postpartum (range 3.3 to 10 months)were taking dextroamphetamine in an average dosage of 18 mg daily (range 15 to 45 mg daily in 2 to 4 divided doses) for attention deficit hyperactivity disorder. The median milk level was 219 mcg/L (range 66 to 313 mcg/L) which resulted in an infant dosage of 21 mcg/kg (range 11 to 39 mcg/kg) daily or 5.7% (range 4 to 10.6%) of the maternal weight-adjusted dosage.[5]

Infant Levels. Dextroamphetamine blood levels were measured in 3 breastfed infants. The mothers of these 3 infants were taking an average of 392 mcg/kg daily of dextroamphetamine. Blood levels in 2 infants were 2 and 18 mcg/L, corresponding to 6 and 14% of the maternal plasma level. The plasma level of the third infant was <1 mcg/L. The times of blood collection were not stated.[5]

Effects in Breastfed Infants

The author of a 1973 newsletter reported a personal communication from the drug manufacturer which stated that of 103 nursing mothers treated with dextroamphetamine (dosage unspecified) for postpartum depression, no infant showed any evidence of stimulation or insomnia.[6]

Four mothers averaging 5.5 months postpartum (range 3.3 to 10 months) were taking dextroamphetamine in an average dosage of 18 mg daily (range 15 to 45 mg daily in 2 to 4 divided doses) for attention deficit hyperactivity disorder. Their infants had been breastfed (extent not stated) since birth. The infants all had weights between the 10th and 75th percentiles for their age, normal progress, and no adverse effects according to their pediatricians. Denver developmental ages for 2 of the infants were 100% and 117% of normal.[5]

In a prospective study, lactating women taking either lisdexamfetamine (Vyvanse®, Shire; n = 6) or mixed racemic amphetamine salts (n = 7) for attention deficit hyperactivity disorder were followed by telephone for several months to 5 years. Seven had also taken one of the drugs during pregnancy. At an average age of follow-up of 18 months, 5 of their 13 infants (5 fully breastfed) had experienced an adverse reaction possibly related to amphetamine in milk; 1 infant had somnolence, 3 had crying or restlessness, and 4 had colic or constipation. Four of these 5 were only partially breastfed from birth onward. All infants had normal Denver developmental scale and pediatric quality of life scores. The authors concluded that therapeutic used of amphetamines is likely compatible with breastfeeding.[7]

Effects on Lactation and Breastmilk

In 2 papers by the same authors, 20 women with normal physiologic hyperprolactinemia were studied on days 2 or 3 postpartum. Eight received dextroamphetamine 7.5 mg intravenously, 6 received 15 mg intravenously and 6 who served as controls received intravenous saline. The 7.5 mg dose reduced serum prolactin by 25 to 32% compared to control, but the difference was not statistically significant. The 15 mg dose significantly decreased serum prolactin by 30 to 37% at times after the infusion. No assessment of milk production was presented.[8,9] The authors also quoted data from another study showing that a 20 mg oral dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40% in postpartum women. The maternal prolactin level in a mother with established lactation may not affect her ability to breastfeed.

In a retrospective Australian study, mothers who used intravenous amphetamines during pregnancy were less likely to be breastfeeding their newborn infants at discharge than mothers who abused other drugs (27% vs 42%). The cause of this difference was not determined.[10]

Alternate Drugs to Consider

(ADHD) Amphetamine, Dextroamphetamine, Methylphenidate; (Narcolepsy) Amphetamine, Armodafinil, Dextroamphetamine, Methylphenidate, Modafinil, Oxybate Salts, Pitolisant

References

1.

Scoten O, Tabi K, Paquette V, et al. Attention-deficit/hyperactivity disorder in pregnancy and the postpartum period. Am J Obstet Gynecol 2024;231:19-35 [PubMed: 38432409]

2.

Oei JL, Kingsbury A, Dhawan A, et al. Amphetamines, the pregnant woman and her children: A review. J Perinatol 2012;32:737-47 [PubMed: 22652562]

3.

AAP Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics 2012;129:e827-41 [PubMed: 22371471]

4.

Wong S, Ordean A, Kahan M. SOGC clinical practice guidelines: Substance use in pregnancy: No. 256, April 2011. Int J Gynaecol Obstet 2011;114:190-202 [PubMed: 21870360]

5.

Wang BP, Li QL, Hu YF. [Impact of epidural anesthesia during delivery on breast feeding]. Di Yi Jun Yi Da Xue Xue Bao 2005;25:114-5, 8 [PubMed: 15684016]

6.

Ayd FJ. Excretion of psychotropic drugs in human breast milk. Int Drug Ther Newsl 1973;8:33-40

7.

Benassayag Kaduri N, Hazan A, De-Haan T, et al. Amphetamine use for attention deficit hyperactive disorder during breastfeeding and children's neurodevelopmental outcomes: A pilot study. Psychiatry Res 2024;339:116047 [PubMed: 38908263]

8.

DeLeo V, Cella SG, Camanni F, et al. Prolactin lowering effect of amphetamine in normoprolactinemic subjects and in physiological and pathological hyperprolactinemia. Horm Metab Res 1983;15:439-43 [PubMed: 6642414]

9.

Petraglia F, De Leo V, Sardelli S, et al. Prolactin changes after administration of agonist and antagonist dopaminergic drugs in puerperal women. Gynecol Obstet Invest 1987;23:103-9 [PubMed: 3583091]

10.

Oei J, Abdel-Latif ME, Clark R, et al. Short-term outcomes of mothers and infants exposed to antenatal amphetamines. Arch Dis Child Fetal Neonatal Ed 2010;95:F36-F41 [PubMed: 19679891]

Substance Name

Lisdexamfetamine

CAS Registry Number

608137-32-2

Drug Class

Breast Feeding

Lactation

Milk, Human

Adrenergic Agents

Central Nervous System Stimulants

Dopamine Agents

Sympathomimetics

Wakefulness-Promoting Agents