- 1Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany. olaf.kelber@bayer.com.
- 2Innovation
& Development, Phytomedicines Supply and Development Center, Bayer
Consumer Health, Steigerwald Arzneimittelwerk GmbH, Havelstr. 5, 64295,
Darmstadt, Germany. olaf.kelber@bayer.com.
- 3Board of the Corporative Members, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.
- 4Bundesverband der Arzneimittel-Hersteller, Bonn, Germany.
- 5Cassella-med GmbH & Co. KG, Cologne, Germany.
- 6Dr. Loges + Co. GmbH, Winsen, Germany.
- 7Institute for Integrative Medicine Siegen, Siegen, Germany.
- 8Medical
Affairs, Phytomedicines Supply and Development Center , Bayer Consumer
Health, Steigerwald Arzneimittelwerk GmbH , Darmstadt, Germany.
- 9Chair of Complementary Medicine, Center of Internal Medicine, Universitätsmedizin Rostock, Rostock, Germany.
- 10Scientific Board, Gesellschaft für Phytotherapie e. V. (GPT), Cologne, Germany.
- 11Institute of Pharmacy, University of Leipzig, Leipzig, Germany.
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.
KEYWORDS:
Benefit–risk assessment; Labeling; Liquid dosing form; Pediatric medicinal product; Phytotherapy
