From the Guidelines
Methylphenidate (Ritalin) can be used safely in lactating mothers, as it is secreted in small amounts in human milk with relative infant doses (RIDs) of <1% and is generally not detected in the blood of breastfed infants, according to the most recent study published in 2024 1.
Key Considerations
- The safety of methylphenidate during breastfeeding is supported by the fact that no adverse effects have been reported in infants, as stated in the study published in the American Journal of Obstetrics and Gynecology 1.
- The American Journal of Obstetrics and Gynecology study suggests that generally, relative infant doses (RIDs) in human milk below 10% are considered safe for breastfeeding, and methylphenidate falls below this threshold 1.
- Another study published in the same journal in 2024 recommends maintaining the therapeutic dose of methylphenidate at the time of delivery and during breastfeeding, emphasizing the importance of weighing the benefits of treatment against potential risks to the infant 2.
Recommendations for Use
- If Ritalin treatment is necessary for the mother's health, such as for attention deficit hyperactivity disorder (ADHD) or narcolepsy, the benefits typically outweigh the potential risks, as most experts consider the level of exposure unlikely to cause adverse effects in breastfed infants.
- Mothers should monitor their infants for unusual irritability, poor feeding, or sleep disturbances, as a precautionary measure.
- Immediate-release formulations may allow for timing doses to minimize exposure, such as taking medication immediately after breastfeeding or during the infant's longest sleep period.
- For mothers requiring treatment, starting with the lowest effective dose is recommended, and the decision to use Ritalin while breastfeeding should be made in consultation with healthcare providers, weighing the mother's need for treatment against potential risks to the infant, as suggested by the study 2.
From the FDA Drug Label
Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0. 7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2. 7. There are no reports of adverse effects on the breastfed infant and no effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methylphenidate hydrochloride oral solution and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride oral solution or from the underlying maternal condition Clinical Considerations Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
Methylphenidate is present in human milk, but there are no reports of adverse effects on the breastfed infant. However, breastfeeding infants should be monitored for adverse reactions. The decision to use methylphenidate in lactating mothers should be made considering the mother's clinical need and the potential risks to the infant. Caution is advised when using methylphenidate in lactating mothers 3.
From the Research
Methylphenidate Use in Lactating Mothers
- The safety of methylphenidate (Ritalin) for use in lactating mothers is a topic of interest, with limited research available.
- A study from 2014 4 found that in cases where children were exposed to methylphenidate through breastfeeding, all cases reported normal development and no adverse effects.
- However, the same study noted that the number and size of the studies found were small, and identified cases were not representative of the general adult ADHD population.
- There is no direct evidence from the other studies 5, 6, 7, 8 to suggest the safety of methylphenidate in lactating mothers, as they primarily focus on the effects of methylphenidate in children and adolescents with ADHD, or its use in adults.
Adverse Events Associated with Methylphenidate
- Studies have reported various adverse events associated with methylphenidate use, including sleep problems, decreased appetite, and increased risk of serious adverse events such as arrhythmia and psychotic disorders 5, 7.
- However, these studies do not specifically address the safety of methylphenidate in lactating mothers.
Limitations of Current Research
- The current research on methylphenidate use in lactating mothers is limited, with small sample sizes and a lack of representative cases 4.
- Further studies are needed to establish the safety and efficacy of methylphenidate in lactating mothers, as well as to identify potential adverse events and their risks 4, 6, 7, 8.