Strattera (Atomoxetine) and Breastfeeding
Caution is advised when using Strattera (atomoxetine) during breastfeeding due to the complete absence of published safety data, though the drug's pharmacokinetic properties suggest it will likely be present in breast milk with unknown effects on nursing infants. 1
Evidence Base and Limitations
The most significant concern is the complete lack of published studies examining atomoxetine use during breastfeeding. 1 This represents a critical knowledge gap that makes evidence-based recommendations challenging.
Pharmacokinetic Concerns
Based on atomoxetine's molecular properties, there are theoretical reasons for concern: 1
- Low molecular weight - facilitates transfer into breast milk
- Long half-life - increases potential for accumulation in milk and infant exposure
- These properties predict atomoxetine will likely be present in human milk, though actual concentrations remain unknown
FDA Labeling Position
The FDA drug label explicitly states: 2
- No data exist on atomoxetine presence in human milk
- No data exist on effects on breastfed infants
- No data exist on effects on milk production
- Atomoxetine is present in animal milk, suggesting human milk transfer is likely
- The label recommends weighing developmental benefits of breastfeeding against maternal clinical need and potential infant risks
Clinical Decision-Making Algorithm
When Atomoxetine May Be Considered
If ADHD symptoms severely impair maternal functioning and alternative treatments are unsuitable, atomoxetine may be continued with close monitoring, as untreated ADHD poses documented risks to both mother and infant. 1
Preferred Alternative Medications
Methylphenidate should be strongly considered as the first-line alternative for breastfeeding mothers requiring ADHD treatment: 1
- Secreted in very small amounts in breast milk (RID <1%)
- Generally not detected in breastfed infant blood 1
- No adverse effects reported in exposed infants 1
- Supported by actual clinical data, unlike atomoxetine 3
Bupropion represents a second-line alternative, particularly for co-occurring depression: 1
- Very limited data (only 21 cases) 1
- Present in human milk at very low levels 1
- Generally no adverse events reported 1
- Important caveat: Two case reports of seizures in breastfed infants exist, though causality uncertain 1
- Less efficacious than stimulants for ADHD treatment 1
Monitoring Requirements If Atomoxetine Is Continued
If atomoxetine must be continued during breastfeeding, implement rigorous infant monitoring: 1
- Weight gain - ensure appropriate growth trajectory
- Developmental milestones - verify infant is meeting age-appropriate benchmarks
- Behavioral changes - watch for irritability, feeding difficulties, or sleep disturbances
- Early and frequent follow-up visits in the first weeks of life
Common Pitfalls to Avoid
Do not automatically discontinue effective ADHD treatment without considering maternal and infant risks. 1 Untreated maternal ADHD can lead to: 1
- Impaired maternal functioning and caregiving ability
- Increased risk of accidents due to impulsivity
- Harm to the mother-infant relationship
- Potential for unintended pregnancy due to impulsivity
Do not assume all ADHD medications carry equal risk during lactation. 1 Methylphenidate has substantially more safety data supporting its use compared to atomoxetine.
Practical Approach
For women planning to breastfeed while on atomoxetine: 1
- Before delivery: Discuss switching to methylphenidate, which has established safety data during lactation
- If switching is not feasible: Engage in detailed risk-benefit discussion acknowledging the absence of safety data
- Consider intermittent dosing: Use medication only when essential for functioning to minimize infant exposure 1
- Establish close monitoring: Schedule frequent pediatric follow-up visits
The fundamental principle: Treatment decisions should balance the well-documented benefits of breastfeeding and maternal mental health treatment against theoretical but unquantified risks to the infant. 1, 2