Hydroxyzine Safety During Breastfeeding
Hydroxyzine should not be given to breastfeeding mothers as stated in the FDA drug label. 1
Evidence Assessment
The FDA drug label explicitly states that hydroxyzine should not be given to nursing mothers because it is unknown whether the drug is excreted in human milk, and since many drugs are excreted this way, caution dictates avoiding its use during breastfeeding 1. This represents the strongest and most direct guidance available on this specific medication.
Clinical Considerations
Pharmacokinetic Concerns
- Hydroxyzine is an antihistamine with sedative properties
- The medication likely passes into breast milk due to its properties, though specific studies on hydroxyzine levels in breast milk are limited
- Sedating antihistamines generally pose concerns for breastfed infants, particularly:
- Risk of sedation in the infant
- Potential for decreased milk production
- Risk of central nervous system effects
Risk Factors to Consider
- Infant age: Infants less than 6 weeks of age require extra caution with medications 2
- Premature or compromised infants may be at higher risk for adverse effects
- Frequency of breastfeeding and volume of milk consumed
Alternative Options
If antihistamine therapy is needed for a breastfeeding mother, consider:
- Non-sedating antihistamines which have better safety profiles during breastfeeding
- Topical treatments when possible to minimize systemic exposure 3
- Non-pharmacological approaches for anxiety or allergic symptoms
Monitoring Recommendations
If hydroxyzine must be used despite recommendations against it (in exceptional circumstances):
- Use the lowest effective dose
- Time administration to minimize infant exposure (immediately after breastfeeding)
- Monitor the infant for:
- Excessive sedation
- Poor feeding
- Decreased alertness
- Changes in sleep patterns
Importance of Breastfeeding Considerations
While medication safety is paramount, it's important to note that the benefits of breastfeeding are substantial 4. However, in this specific case, the FDA guidance against hydroxyzine use during breastfeeding is clear 1. The risk assessment should consider both the potential risks of the medication to the infant and the benefits of continued breastfeeding 5.
Key Takeaway
Based on the FDA drug label, hydroxyzine should be avoided during breastfeeding. Alternative medications with established safety profiles in lactation should be selected when treatment is necessary for the mother.