Arbitman Leah, Chen Shirley, Kim Brian, Lee Melinda, Zou Peng, Doughty Bennett, Li Yanyan, Zhang Tao
School of Pharmacy and Pharmaceutical Sciences, SUNY-Binghamton University, 96 Corliss Ave, Johnson City, NY 13790, USA.
Daiichi Sankyo Inc., 211 Mount Airy Road, Basking Ridge, NJ 07920, USA.
Pharmaceutics. 2024 Jun 22;16(7):847. doi: 10.3390/pharmaceutics16070847.
Despite the prevalence of depression in lactating mothers, there is a lack of knowledge about the excretion of antidepressants into breast milk and its potential adverse effects on infants. This creates concern, making depressed lactating mothers more likely to avoid pharmacological treatment. Clinical lactation studies are the most accurate and direct method to predict and demonstrate the excretion of antidepressants into human breast milk, and results from clinical studies can be included in drug labels to help physicians and patients make decisions on antidepressant use during lactation. However, there are limited clinical trials and studies on the pharmacokinetics of antidepressants in lactating women because of a lack of enrollment and ethical and confounding factors, creating a lack of knowledge in this area. To bridge this gap in knowledge, alternative methods should be sought to help estimate the antidepressant concentration in breast milk, which is used to assess the safety and transfer of antidepressants into breast milk. We provide a comprehensive review of the usage of these cost-effective, time-efficient, and ethically feasible methods that serve to provide a valuable estimation of the safety and transfer of antidepressants into breast milk before conducting clinical studies.
尽管哺乳期母亲中抑郁症很普遍，但对于抗抑郁药在母乳中的排泄情况及其对婴儿的潜在不良影响，人们了解不足。这引发了担忧，使得患抑郁症的哺乳期母亲更有可能避免药物治疗。临床泌乳研究是预测和证明抗抑郁药在人母乳中排泄情况的最准确、最直接的方法，临床研究结果可纳入药品标签，以帮助医生和患者就哺乳期使用抗抑郁药做出决策。然而，由于缺乏入组以及伦理和混杂因素，关于哺乳期妇女抗抑郁药药代动力学的临床试验和研究有限，导致该领域知识匮乏。为了弥补这一知识空白，应寻求替代方法来帮助估计母乳中的抗抑郁药浓度，该浓度用于评估抗抑郁药进入母乳的安全性和转移情况。我们全面综述了这些具有成本效益、省时且符合伦理的可行方法的使用情况，这些方法有助于在开展临床研究之前，对抗抑郁药进入母乳的安全性和转移情况提供有价值的估计。
