Warrer Pernille, Aagaard Lise, Hansen Ebba Holme
Section for Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark,
Drug Saf. 2014 Oct;37(10):805-13. doi: 10.1007/s40264-014-0215-2.
Pregnancy and lactation labeling is presented in the officially recognized product information (PI) accompanying prescription drugs to ensure appropriate prescribing in pregnant and breastfeeding women.
The aim of this study was to analyze pregnancy and lactation labeling in PI for attention-deficit hyperactivity disorder drugs marketed across countries and to compare this information with respect to consistency and discrepancy.
We manually surveyed PI for atomoxetine, methylphenidate, and modafinil marketed by the same pharmaceutical companies in Australia, the USA, Denmark, and the UK. We extracted information regarding data sources (animal and human data), risk to the fetus or breastfed child, excretion in breast milk, and recommendations for use. The extracted information was then analyzed and compared with respect to consistency and discrepancy.
Inter-country discrepancies were identified with respect to both animal and human data sources presented, types of risks listed in association with exposure during pregnancy and lactation, information regarding excretion of the drug in breast milk, and recommendations for use. Consistency was identified between PI for drugs marketed in the EU.
The study suggests that pregnancy and lactation labeling in PI for drugs marketed by the same pharmaceutical companies depend on the country of marketing; this raises concern about the reliability of PI documents as a useful source of information for appropriate prescribing during pregnancy and lactation. Discrepancies in this information can potentially lead to inappropriate prescribing in pregnant and breastfeeding women, who may expose their fetuses and breastfed children to unnecessary risks. At the same time, unjustified warnings against breastfeeding may result in children being unnecessarily weaned from being breastfed.
妊娠和哺乳期标签包含在处方药随附的官方认可的产品信息（PI）中，以确保对孕妇和哺乳期妇女进行适当的处方。
本研究的目的是分析各国销售的注意力缺陷多动障碍药物的PI中的妊娠和哺乳期标签，并比较这些信息在一致性和差异方面的情况。
我们手动调查了澳大利亚、美国、丹麦和英国同一家制药公司销售的托莫西汀、哌甲酯和莫达非尼的PI。我们提取了有关数据来源（动物和人类数据）、对胎儿或母乳喂养儿童的风险、药物在母乳中的排泄以及使用建议的信息。然后对提取的信息进行分析，并比较其一致性和差异。
在所呈现的动物和人类数据来源、与孕期和哺乳期接触相关列出的风险类型、药物在母乳中的排泄信息以及使用建议方面，发现了国家间的差异。在欧盟销售的药物的PI之间发现了一致性。
该研究表明，同一家制药公司销售的药物的PI中的妊娠和哺乳期标签取决于销售国家；这引发了对PI文件作为孕期和哺乳期适当处方有用信息来源的可靠性的担忧。这些信息的差异可能会导致对孕妇和哺乳期妇女的处方不当，她们可能会使胎儿和母乳喂养的儿童面临不必要的风险。同时，对母乳喂养的不合理警告可能会导致儿童不必要地断奶。
