title: Ethanol in herbal medicinal products for children : Data from pediatric studies and pharmacovigilance programs.
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.
authors.affiliation: Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany. olaf.kelber@bayer.com.|Innovation & Development, Phytomedicines Supply and Development Center, Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295, Darmstadt, Germany. olaf.kelber@bayer.com.
authors.forename: Olaf
authors.initials: O
authors.lastname: Kelber
authors.affiliation: Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.|Bundesverband der Arzneimittel-Hersteller, Bonn, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Steinhoff
authors.affiliation: Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.|Cassella-med GmbH & Co. KG, Cologne, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Nauert
authors.affiliation: Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.|Dr. Loges + Co. GmbH, Winsen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Biller
authors.affiliation: Institute for Integrative Medicine Siegen, Siegen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Adler
authors.affiliation: Medical Affairs, Phytomedicines Supply and Development Center , Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH , Darmstadt, Germany.
authors.forename: Heba
authors.initials: H
authors.lastname: Abdel-Aziz
authors.affiliation: Medical Affairs, Phytomedicines Supply and Development Center , Bayer Consumer Health, Steigerwald Arzneimittelwerk GmbH , Darmstadt, Germany.
authors.forename: Samuel N
authors.initials: SN
authors.lastname: Okpanyi
authors.affiliation: Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.|Chair of Complementary Medicine, Center of Internal Medicine, Universitätsmedizin Rostock, Rostock, Germany.
authors.forename: Karen
authors.initials: K
authors.lastname: Kraft
authors.affiliation: Scientific Board, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.|Institute of Pharmacy, University of Leipzig, Leipzig, Germany.
authors.forename: Karin
authors.initials: K
authors.lastname: Nieber
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D004348:Drug Labeling; D000431:Ethanol / Q000009:adverse effects*; D006801:Humans; D014677:Pharmaceutical Vehicles / Q000009:adverse effects*; D060735:Pharmacovigilance; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D014677:Pharmaceutical Vehicles; D010936:Plant Extracts; D000431:Ethanol
keywords: Benefit–risk assessment; Labeling; Liquid dosing form; Pediatric medicinal product; Phytotherapy