Ethanol in herbal medicinal products for children

Abstract

SummaryHerbal 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.

Evaluation of Blood Alcohol Concentrations after Oral Administration of a Fixed Combination of Thyme Herb and Primrose Root Fluid Extract to Children with Acute Bronchitis

“…Clinical studies document effective amelioration of typical symptoms such as cough, sputum and dyspnoea [1,2]. In herbal medicinal products, alcohol (ethanol) serves as the extractant for more lipophilic active agents, e. g. ethereal oils [3]. It is also involved in the stabilisation and resorption processes of the drug [4].…”

“…It is also involved in the stabilisation and resorption processes of the drug [4]. Despite long-term safe use, the application of ethanol-containing herbal medicinal products to children has been a subject of discussion for many years among experts and consumers [3,5,6]. The issue is often seen against the background of intoxications and impairments because of ethanol embryopathy and ethanol abuse by adolescents [7][8][9].…”

“…In this clinical study, the blood ethanol concentration after oral administration of a fixed combination of thyme herb and primrose root fluid extract was investigated in paediatric patients. Pharmacokinetic and pharmacodynamic data on the use of ethanol in children are very rare [3,5].Most data derive from retrospective evaluations of accidental or abusive ethanol ingestions.…”

“…Despite their safe and effective use for many years, controversy over the application of ethanol-containing medicinal products to children has not stopped [3,6]. Critics often refer to intoxications of adolescents and adverse effects on the foetus due to alcohol abuse and demand zero % alcohol in medicines for children.…”

Phytotherapy in Functional Gastrointestinal Disorders

“…Overall, the incidence of reports in the approximately 78 million patients to date who have used the product is very low. With respect to the ethanol content of the pharmaceutical form, modern assessments confirm the lack of any relevant risk not only in adults, but also in children [25, 26]. The favorable benefit profile also includes elderly patients [27].…”