Planta Med 2012; 78 - PH19
DOI: 10.1055/s-0032-1320678

Ethanol in herbal medicinal products for children: Study data from 50.425 children support safety

O Kelber 1, B Steinhoff 2, C Nauert 3, A Biller 4, M Adler 5, H Abdel-Aziz 1, SN Okpanyi 1, K Nieber 6, K Kraft 7
  • 1Scientific Department, Steigerwald Arzneimittelwerk GmbH, 64295 Darmstadt, Germany
  • 2Bundesverband der Arzneimittel-Hersteller, 53173 Bonn, Germany
  • 3Cassella-med GmbH & Co. KG, 50670 Cologne, Germany
  • 4Dr. Loges + Co. GmbH, 21423 Winsen, Germany
  • 5Institute for Integrative Medicine Siegen, 57078 Siegen, Germany
  • 6University of Leipzig, Institute of Pharmacy, 04103 Leipzig, Germany
  • 7Chair of Naturopathy, Center for Internal Medicine, University of Rostock, 18057 Rostock, Germany

Many herbal medicinal products for use in children contain ethanol. For answering the question, whether this is safe, a systematic evaluation of pro- and retrospective studies as well as a broad survey of market figures and pharmacovigilance data was conducted. Therefore, 17 studies covering 50.425 children aged 0–12 years were evaluated. None of the 15 adverse events reported were related to the ethanol content of the products. During the past few years more than 764 million daily doses have been sold. In terms of packages, 10.8 millions sold in Germany were reimbursed by the health insurance between 2005 and 2009, which indicates that they were prescribed to children. In parallel, no adverse effects attributable to the ethanol content have been reported, showing that the ethanol content of herbal medicinal products does not give causes for concerns, even regarding their safety in children.

Dedication to: † Prof. Dr. Hilke Winterhoff, Institute for Pharmacology and Toxicology, Münster