Year: 2026
Type: preprint
Study design: Observational Study
Abstract: Objective Amphetamine (AMP) and its derivates are commonly prescribed for the management of attention-deficit/hyperactivity disorder (ADHD). This study aimed to 1) quantify AMP’s transfer into human milk in lactating women receiving therapeutic doses and 2) contextualize infant exposure. Methods Milk 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 (RID mat ) and RID standardized to the defined daily dose (RID DDD ) of 15 mg AMP base. Results Average milk concentrations (C avg ) of AMP base ranged from 23.3 to 297.0 ng/mL and increased linearly (R² = 0.92) with maternal daily dose. The RID mat ranged 3.6–10.8% and RID DDD ranged 1.4–21.8%. The fitted regression line crossed the 10% RID DDD threshold at 1.17× DDD, with the upper 95% prediction limit crossing at 0.84× DDD. No adverse event reported by the mother–infant dyads were attributed to AMP exposure, notably including absence of reduced milk supply. Conclusions The 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.
Source: medRxiv
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: Texas Tech University
OpenAlex ID: W7222998174