Colaceci Sofia, Giusti Angela, Chapin Elise Merrill, Notarangelo Micaela, De Angelis Alessia, Vellone Ercole, Alvaro Rosaria
1 Department of Biomedicine and Prevention, University of Rome Tor Vergata , Rome, Italy .
2 National Center of Epidemiology, Surveillance, and Health Promotion, National Institute of Health , Rome, Italy .
Breastfeed Med. 2015 Dec;10(10):468-73. doi: 10.1089/bfm.2015.0086. Epub 2015 Nov 13.
The lack of consistent official information on the use of medications during lactation is probably one of the main reasons leading to an excess of prudence, based on presumption of risk rather than on evidence. The objective of this study was to compare the level of agreement between different official sources available to doctors and women on the use of medications during lactation.
Sources of information included governmental regulatory agencies (RAs) and scientific sources (SS). The package leaflets (PLs) and summaries of product characteristics (SPCs) were retrieved from online databases of the European Union and U.S. RAs. Among the SS, the latest edition of the book Medications and Mothers' Milk by Hale and Rowe and the LactMed database were selected. Information about the use of 11 antihypertensive medications during breastfeeding was analyzed.
The PLs and SPCs report a higher risk profile than the one expressed by SS, and they often suggest the interruption of lactation even for compatible medications.
Health professionals should be supported by official, accurate, comprehensive, and consistent information about maternally ingested medication and breastfeeding management to facilitate proper decision-making.
哺乳期用药缺乏一致的官方信息，这可能是导致过度谨慎的主要原因之一，这种谨慎基于风险推测而非证据。本研究的目的是比较医生和女性可获取的不同官方来源关于哺乳期用药的一致程度。
信息来源包括政府监管机构（RAs）和科学来源（SS）。药品说明书（PLs）和产品特性摘要（SPCs）从欧盟和美国监管机构的在线数据库中获取。在科学来源中，选取了黑尔和罗所著《药物与母乳》的最新版本以及哺乳药物数据库。分析了11种抗高血压药物在母乳喂养期间的使用信息。
药品说明书和产品特性摘要所报告的风险状况高于科学来源所表达的，并且它们常常建议即使是相容性药物也应中断哺乳。
官方应提供关于母亲摄入药物及母乳喂养管理的准确、全面且一致的信息，以支持卫生专业人员做出恰当决策。
