▪ 약물의 분류: 항히스타민제
▪ 임신부 약물등급(US FDA): C
▪ 임신부 안전 및 기형발생정보:
Hydroxyzine produced adverse pregnancy effects in rodents. There is limited published experience during human pregnancy.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): L2
▪ 모유수유 안전 및 유해성정보:
The product labeling for hydroxyzine suggests that it be avoided by nursing mothers because of the possibility that the drug is excreted in milk. No information was presented on what adverse effects, if any, might be expected from such exposure.
One investigation questioned women who used antihistamines for seasonal allergies or colds while lactating and found that mothers noted irritability, drowsiness, or decreased sleep in their neonates in 22.6% of the study population. No side effect was serious enough for a mother to seek medical attention for the infant. In another study by these investigators, minor adverse reactions that did not require medical attention were reported in infants by 9.4% of the mothers using antihistamines. The most commonly observed effect in 6 of 8 reports was irritability. In a French pharmacovigilance database study, there were 8 reports of adverse effects, primarily sedation, in breastfed infants exposed to hydroxyzine.
Because of their anticholinergic effects, antihistamines might, in theory, reduce milk production. In spite of this theoretical concern, we did not locate data demonstrating such an effect. Advice to women on the use of these agents can be based on the generally reassuring reports that have been published and on the available reports indicating that low concentrations of other antihistamines appear in milk. If anticholinergic effects of antihistamines result in a decrease in milk supply, we assume that such an effect would resolve on discontinuation of the medication, but we are not aware of data on this question.
If jitteriness or poor feeding develop in a nursing infant with maternal use of antihistamines, it would be reasonable to stop the medication or to switch to formula feeding and look for resolution of the infant`s symptoms.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
히드록시진에 노출된 후 추적된 임신부는 총 104례이었으며 초기 노출 후 자연유산율은 5.7%(6/104)이었다. 임신 37주 이전의 조산률은 4.3%(4/94), 2,500 g 미만의 저체중증은 3.2%(3/93)
이었다. 주요기형발생은 3.2%(3/93): nevus(3×3 ㎝) on wrist(1), both hands polydactyly(1), scalp mass and anal dimpling(1)가 있었다. 그리고 사산 2례가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 12쌍 중 졸음 1례 있었다.