From the Guidelines
Hydroxyzine is generally considered safe during breastfeeding, particularly at typical doses [ 1 ].
Key Considerations
- The amount of hydroxyzine present in breast milk is minimal, with estimated infant exposure ranging from 0.7-1.3% of the maternal weight-adjusted dose [ 1 ].
- Caution is advised with prolonged use or higher doses, as the potential for sedative effects on the infant cannot be entirely ruled out [ 1 ].
- While there are concerns about the use of hydroxyzine during the first trimester of pregnancy based on animal data [ 1 ], the context of breastfeeding is distinct and the available evidence supports its safety in this scenario.
- It is essential to weigh the benefits of hydroxyzine use against the potential risks and to monitor the infant for any signs of sedation or other adverse effects [ 1 ].
Recommendations
- Hydroxyzine can be used during breastfeeding at typical doses, such as 25-50mg every 6-8 hours, for short-term durations [ 1 ].
- Close monitoring of the infant for any signs of sedation or other adverse effects is recommended, especially with prolonged use or higher doses [ 1 ].
From the FDA Drug Label
Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.
- Hydroxyzine safety during breastfeeding: The FDA recommends that hydroxyzine should not be given to nursing mothers due to the uncertainty of its excretion in human milk.
- Key consideration: The lack of information on the drug's excretion in human milk leads to a precautionary approach, advising against its use in breastfeeding mothers 2
From the Research
Safety of Hydroxyzine During Breastfeeding
- The safety of hydroxyzine during breastfeeding is not directly addressed in the provided studies, but general information about antihistamines can be applied.
- According to 3, all antihistamines are considered safe to use during breastfeeding, as minimal amounts are excreted in the breast milk and would not cause any adverse effects on a breastfeeding infant.
- A study published in 4 found that the relative infant dose of antihistamines, including some that are similar to hydroxyzine, was below 5%, indicating that the amount of drug transferred to the infant through breast milk is likely to be small.
- However, the same study 4 notes that the knowledge gap on antihistamines and lactation is extensive, and further human studies are warranted to ensure optimal treatment of breastfeeding women with allergy.
- Another study 5 mentions that most commonly used drugs, including antihistamines, are relatively safe for breastfed babies, but it is essential to consider the principles underlying the transfer into breast milk and the potential adverse effects on the infant.
- The concept of relative infant dose (RID) is discussed in 6, which can be used to estimate the exposure of the breastfed infant to a drug, but this study does not specifically address hydroxyzine.