Kelber Olaf, Steinhoff Barbara, Nauert Christian, Biller Andreas, Adler Martin, Abdel-Aziz Heba, Okpanyi Samuel N, Kraft Karen, Nieber Karin
Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.
Innovation & Development, Phytomedicines Supply and Development Center, Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany.
Wien Med Wochenschr. 2017 May;167(7-8):183-188. doi: 10.1007/s10354-016-0474-x. Epub 2016 Jul 28.
Herbal medicinal products are indispensable in children, e. g., in functional gastrointestinal diseases and coughs and colds, especially when available in liquid dosing forms for which dosing can be adapted ideally to different age groups. Despite being generally accepted as safe, the ethanol content of many of these products, necessary for Galenic reasons, has raised questions regarding their safety. Therefore, safety data from more than 50,000 children in noninterventional pediatric studies with these products, as well as data from routine clinical use in several million children, were assessed. No evidence of the involvement of the ethanol content in any adverse drug reactions was found. This allows us to conclude that these herbal medicinal products are safe in the age groups for which they are authorized or registered and that the present labeling is adequate to allow for their safe use in the pediatric population.
草药产品在儿童中是不可或缺的，例如在功能性胃肠疾病以及咳嗽和感冒方面，特别是当有液体剂型可供使用时，其剂量可以理想地适应不同年龄组。尽管这些产品通常被认为是安全的，但由于盖伦制剂方面的原因，其中许多产品的乙醇含量引发了对其安全性的质疑。因此，评估了在使用这些产品的非干预性儿科研究中50000多名儿童的安全数据，以及数百万儿童常规临床使用的数据。未发现乙醇含量与任何药物不良反应有关的证据。这使我们能够得出结论，这些草药产品在其获批或注册的年龄组中是安全的，并且目前的标签足以确保其在儿科人群中的安全使用。
