Koh Yun Pei, Tian Elizabeth A, Oon Hazel H
National Skin Centre, Singapore, Singapore.
Int J Womens Dermatol. 2019 May 16;5(4):216-226. doi: 10.1016/j.ijwd.2019.05.002. eCollection 2019 Sep.
The U.S. Food and Drug Administration has published new pregnancy and lactation labelling rules that set standards on the presentation of information with regard to drug usage during pregnancy and breastfeeding, as well as the effects on fertility. These guidelines became effective June 30, 2015, and classified the risks of using prescription drugs during pregnancy in three detailed subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. These sections describe the risks within a real-world context of caring for these patients.
In this study, we reclassified and categorized drugs and treatments commonly used in dermatology according to these new guidelines.
We performed a search of the medical literature about the use of relevant prescription drugs during pregnancy and breastfeeding and their effect on fertility. The search included prospective and retrospective studies, review articles from PubMed-indexed journals (from inception to November 2018), U.S. Food and Drug Administration records, pregnancy exposure registries, relevant information and studies provided in drug labeling by companies, and updated pharmacologic texts and guidelines up to 2018.
Topical immunomodulators, systemic immunomodulators (including biologics), systemic antipruritic agents, antimicrobials, as well as acne, hair, and cosmetic agents were included. We have made best attempts to review and consolidate existing and new data and include them in our guide.
This new narrative format facilitates prescribing by considering a variety of factors. One previously overlooked aspect was the impact on the reproductive potential of both male and female patients. Rather than depending on overly simplistic letter risk categories, dermatologists will now need to make prescribing decisions based on each patient and the information provided, which will allow for better decision making and patient care.
美国食品药品监督管理局发布了新的妊娠和哺乳期标签规则，该规则为孕期和哺乳期用药信息的呈现以及对生育能力的影响设定了标准。这些指南于2015年6月30日生效，并将孕期使用处方药的风险详细分为三个子部分：妊娠、哺乳以及有生殖潜力的女性和男性。这些部分在照顾这些患者的实际背景下描述了风险。
在本研究中，我们根据这些新指南对皮肤科常用的药物和治疗方法进行了重新分类和归类。
我们检索了关于孕期和哺乳期使用相关处方药及其对生育能力影响的医学文献。检索内容包括前瞻性和回顾性研究、来自PubMed索引期刊（从创刊到2018年11月）的综述文章、美国食品药品监督管理局的记录、妊娠暴露登记处、公司药品标签中提供的相关信息和研究，以及截至2018年的更新药理学文本和指南。
纳入了局部免疫调节剂、全身免疫调节剂（包括生物制剂）、全身止痒剂、抗菌剂以及痤疮、毛发和美容剂。我们已尽力回顾和整合现有及新数据，并将其纳入我们的指南。
这种新的叙述形式通过考虑多种因素促进了处方开具。一个以前被忽视的方面是对男性和女性患者生殖潜力的影响。皮肤科医生现在无需依赖过于简单的字母风险类别，而是需要根据每位患者和所提供的信息做出处方决定，这将有助于做出更好的决策和提供更优质的患者护理。
