Introduction:
Liquid dosage forms of phytomedicines are very suitable for children, as they allow the adaption of the dose to the age group. However, as they contain ethanol in many cases, they have been repeatedly triggering critical questions.
Materials and Methods:
Therefore, data from non-interventional studies on herbal medicinal products containing ethanol were evaluated. In addition, analytical data for ethanol in food items usual for children were generated by gas chromatography and a scenario for the exposure of a 6 year-old child to ethanol through food intake was generated.
Results and Discussion:
When using common herbal medicinal products, an estimation of the ethanol intake for a 6 year-old child reults in a dose of between 70 and 180 mg per single dose. With an intake 3 times daily and related to a body weight [b.w.] of 20 kg, this is 10.1 – 27.0 mg/kg per day [1].
An evaluation of the side effects of these herbal medicinal products was based on non-interventional studies in more than 50.000 children and on spontaneous reports from the use in approximately 3 million children, and did not reveal any ethanol related side effects.
For evaluating the uptake of ethanol with food items commonly used in children, ethanol contents in food items were measured [3]. Based on these data, a scenario for the mean ethanol exposure was developed, using data on nutritional habits from USA and Germany. The resulting scenarios lead to an uptake of up to 12.5 – 23.3 mg/kg b.w..
Conclusions:
According to these data, the ethanol uptake with herbal medicinal products in children is in an order of magnitude comparable to everyday exposure with usual food items, and therefore there is no cause for toxicological concerns.
References
[1] Kelber O et al. PharmInd 2008, 70:1124–1127
[2] Kelber O et al. Wien Med Wochenschr 2016, 167:183-188
[3] Gorgus E et al. J Analyt Toxicol 2016, doi:10.1093/jat/bkw046