Bilastine Safety During Lactation
Bilastine has no available clinical data in breastfeeding mothers, so safety during lactation is uncertain. [1] LactMed recommends considering an alternate drug during breastfeeding, especially when nursing a newborn or preterm infant. [1] If bilastine is used during breastfeeding, infant monitoring for sedation, poor feeding, and poor weight gain is recommended. [1]
Evidence on Transfer Into Breast Milk
It is unknown whether bilastine is excreted in human milk. [2] Excretion into milk has been shown in lactating rats after a single oral dose. [2] The relevance of animal milk transfer data to humans is unknown. [2]
Recommended Use Strategy
An alternate antihistamine is preferred during breastfeeding because of lack of human lactation data. [1] If bilastine is used despite limited evidence, monitoring for infant adverse effects is recommended. [1]
Infant Monitoring During Bilastine Use
Monitoring should focus on sedation in the breastfed infant. [1] Monitoring should include assessment for poor feeding in the breastfed infant. [1] Monitoring should include assessment for poor weight gain in the breastfed infant. [1]
Alternate Antihistamines to Consider
LactMed lists cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine as alternate drugs to consider during lactation. [1]
Practical Clinical Considerations
Bilastine use during lactation should be approached as an evidence-limited decision because published information on maternal and infant exposure and effects is not available. [1] Animal data indicate milk transfer, but human relevance remains uncertain. [2]
Common Clinical Decision Point
Use of an alternate drug is favored when safer options are available, particularly for newborns and preterm infants. [1]