▪ 약물의 분류: 이담제
▪ 임신부 약물등급(US FDA): B
▪ 임신부 안전 및 기형발생정보 :
Ursodeoxycholic acid did not interfere with embryo development in rats. There are several reports of normal human pregnancy outcome after second and third trimester treatment.
▪ 모유수유부 약물등급(Medication and Mother’s MilK): 정보없음
▪ 모유수유 안전 및 유해성정보 :
Ursodeoxycholic acid is excreted in human milk in small amounts. Ursodeoxycholic acid was reported as undetectable in the milk of a woman who took 750 mg daily throughout pregnancy and postpartum.
The concentrations of this agent in milk were lower in seven women taking it therapeutically than the concentrations found in women with untreated primary biliary cirrhosis. A 2010 report described normal development in the nursing infant of a woman with primary biliary cirrhosis who began taking 500 mg/day ursodeoxycholic acid during her 5th week of lactation and continued with 1500 mg/day after her 11th week. Her milk concentration of this agent was less than 0.5 mcM throughout lactation. Normal infant development was also reported in other cases where this agent was used during lactation.
▪ 한국마더세이프전문상담센터 DB 정보 (모태독성학2016):
우루소데스옥시콜린산에 노출된 후 추적된 임신부는 총 60례이었으며 초기 노출 후 자연유산율은 6.6%94/60)이었다. 임신 37주 이전의 조산률은 3.8%(2/52), 2,500 g 미만의 저체중증은
3.8%(2/52)이었다. 주요기형발생은 9.6%(5/52): pulmonary artery stenosis(1), mega cisterna magna(13.6 ㎜)(1), both club foot with right wrist drop(1), fetal hydrops(1), right inguinal hernia(1)가 있었다. 그리고 사산 2례가 있었다.
2) 모유 수유 시 독성 및 적합성 정보
수유부-수유아 2쌍 중 부작용 사례는 없었다