Focus or Feeding: A Quantitative Analysis of Prescribed Amphetamines in Human Milk

Abstract

ObjectiveAmphetamine (AMP) and its derivates are commonly prescribed for the management of attention-deficit/hyperactivity disorder (ADHD). This study aimed to 1) quantify AMPs transfer into human milk in lactating women receiving therapeutic doses and 2) contextualize infant exposure.

MethodsMilk samples and dyad health histories of thirteen lactating women treated with varying doses of either mixed AMP, dextroamphetamine, or lisdexamfetamine were released for this study from the InfantRisk Human Milk Biorepository. Milk drug concentrations were quantified by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) and used to calculate standard relative infant dose (RIDmat) and RID standardized to the defined daily dose (RIDDDD) of 15 mg AMP base.

ResultsAverage milk concentrations (Cavg) of AMP base ranged from 23.3 to 297.0 ng/mL and increased linearly (R{superscript 2} = 0.92) with maternal daily dose. The RIDmat ranged 3.6-10.8% and RIDDDD ranged 1.4-21.8%. The fitted regression line crossed the 10% RIDDDD threshold at 1.17x DDD, with the upper 95% prediction limit crossing at 0.84x DDD. No adverse event reported by the mother-infant dyads were attributed to AMP exposure, notably including absence of reduced milk supply.

ConclusionsThe levels of AMP observed in human milk followed a dose predictable manner. The average patient was predicted to remain below the 10% RID DDD safety threshold at total daily doses at or below approximately 28 mg of mixed AMP salts or 59 mg of lisdexamfetamine. Ninety-five percent of patients were predicted to remain below the threshold at or below approximately 20 mg and 40 mg, respectively.

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BibTeX RIS

BibTeX

@misc{yamada2026focus,
  title = {{Focus or Feeding: A Quantitative Analysis of Prescribed Amphetamines in Human Milk}},
  author = {E. Yamada and A. Stark and J. Burdine and L. Donikini and P. Datta and K. Krutsch},
  howpublished = {medRxiv},
  year = {2026},
  month = oct,
  doi = {10.64898/2026.10.14.26365136},
  url = {https://www.medrxiv.org/content/10.64898/2026.10.14.26365136v1},
  note = {CC BY-NC-ND},
}

RIS

TY  - UNPB
TI  - Focus or Feeding: A Quantitative Analysis of Prescribed Amphetamines in Human Milk
AU  - E. Yamada
AU  - A. Stark
AU  - J. Burdine
AU  - L. Donikini
AU  - P. Datta
AU  - K. Krutsch
PY  - 2026
DA  - 2026/10/14
PB  - medRxiv
DO  - 10.64898/2026.10.14.26365136
UR  - https://www.medrxiv.org/content/10.64898/2026.10.14.26365136v1
AB  - ObjectiveAmphetamine (AMP) and its derivates are commonly prescribed for the management of attention-deficit/hyperactivity disorder (ADHD). This study aimed to 1) quantify AMPs transfer into human milk in lactating women receiving therapeutic doses and 2) contextualize infant exposure.  MethodsMilk samples and dyad health histories of thirteen lactating women treated with varying doses of either mixed AMP, dextroamphetamine, or lisdexamfetamine were released for this study from the InfantRisk Human Milk Biorepository. Milk drug concentrations were quantified by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) and used to calculate standard relative infant dose (RIDmat) and RID standardized to the defined daily dose (RIDDDD) of 15 mg AMP base.  ResultsAverage milk concentrations (Cavg) of AMP base ranged from 23.3 to 297.0 ng/mL and increased linearly (R{superscript 2} = 0.92) with maternal daily dose. The RIDmat ranged 3.6-10.8% and RIDDDD ranged 1.4-21.8%. The fitted regression line crossed the 10% RIDDDD threshold at 1.17x DDD, with the upper 95% prediction limit crossing at 0.84x DDD. No adverse event reported by the mother-infant dyads were attributed to AMP exposure, notably including absence of reduced milk supply.  ConclusionsThe levels of AMP observed in human milk followed a dose predictable manner. The average patient was predicted to remain below the 10% RID DDD safety threshold at total daily doses at or below approximately 28 mg of mixed AMP salts or 59 mg of lisdexamfetamine. Ninety-five percent of patients were predicted to remain below the threshold at or below approximately 20 mg and 40 mg, respectively.
ER  -

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