Ethanol in herbal medicinal products for children : Data from pediatric studies and pharmacovigilance programs.

Olaf Kelber, Barbara Steinhoff, Christian Nauert, Andreas Biller, Martin Adler, Heba Abdel-Aziz, Samuel N Okpanyi, Karen Kraft, Karin Nieber

Journal: Wiener medizinische Wochenschrift (1946) 2018;167(7-8):183-188

PMID: 27468971

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Abstract

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.

Address: Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany. [email protected].; Innovation & Development, Phytomedicines Supply and Development Center, Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany. [email protected].; Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.; Bundesverband der Arzneimittel-Hersteller, Bonn, Germany.; Cassella-med GmbH & Co. KG, Cologne, Germany.; Dr. Loges + Co. GmbH, Winsen, Germany.; Institute for Integrative Medicine Siegen, Siegen, Germany.; Medical Affairs, Phytomedicines Supply and Development Center , Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH , Darmstadt, Germany.; Chair of Complementary Medicine, Center of Internal Medicine, Universitätsmedizin Rostock, Rostock, Germany.; Scientific Board, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.; Institute of Pharmacy, University of Leipzig, Leipzig, Germany.

DOI: 10.1007/s10354-016-0474-x

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MeSH Terms: Adverse Drug Reaction Reporting Systems, Drug Labeling, Ethanol, Humans, Pharmaceutical Vehicles, Pharmacovigilance, Phytotherapy, Plant Extracts