Prof. Dr. Yıldız Atamer made statements about the ethanol substance used in herbal, pediatric drugs, alcoholic beverages and disinfectants and the symptoms that may be experienced in children exposed to this substance. Stating that the most important problem in herbal products used in children is the amount of ethanol they contain, Atamer said, “This is a toxicological problem in children in terms of both short-term and long-term use of ethanol-containing herbal medicinal products, which are mainly used and marketed without a prescription, and ethanol use in herbal products has some concerns. increases ”he said.
‘IT SHOULD NOT BE FORGOTT THAT MORE THAN ONE SUBSTANCE CAN BE DELIVERED AT THE SAME TIME’
Warning that newborns, infants and children cannot metabolize ethanol as efficiently as adults, Atamer used the following statements;
“Safety limits are needed for ethanol exposure of oral herbal medicinal products for children. It should be noted that in many liquid plant extracts, ethanol is not an excipient, but part of the active substance. It should also be remembered that more than one herbal medicinal product containing ethanol can be given to a child at the same time. Ethanol is metabolically active. Therefore, formulations that do not contain ethanol or have the lowest achievable level should be selected to avoid systemic exposure when the target population is children ”.
‘THE EU IS COMMONLY USING PEDIATRIC DRUGS’
Stating that the use of ethanol as an excipient in pediatric drugs is still widespread in Europe and recent literature data show potential danger in the neonatal and pediatric ages, Atamer said, “The safety assessment of the ethanol content of herbal medicinal products for pediatric use is currently not harmonized between different EU member states. . Concerns about children’s exposure to ethanol and its impact on public health have also recently been raised by the European Commission. The FDA has provided labeling guidelines for over-the-counter drug products containing ethanol designed for oral administration. This guide is mainly based on results from the 1984 Pediatrics publication of the American Academy of Pediatrics. Recommendations regarding ethanol threshold for oral liquid preparations given to children; “Medical prescription drugs intended for pediatric use in France should have an ethanol concentration of less than 5 percent, or the amount of ethanol in any medicinal product should not produce a blood ethanol concentration of more than 0.125 g / L following administration of just one dose,” he said.
“ SYMPTOMS OF ETHANOL POISONING IN CHILDREN MAY BE SERIOUS ”
Stating that ADH activity (alcohol dehydrogenase liver enzyme, mainly responsible for ethanol metabolism) is low in children, Atamer continued as follows:
“Symptoms of ethanol poisoning in children are similar to those in adults but can be more severe. Milder side effects such as dizziness are expected to occur at much lower concentrations. The life-threatening blood ethanol concentration, which is usually reported to be around 3 g / L (3%) in adults, may be lower in children, as it has already been reported that up to 50 percent higher mortality in children at 1 g / L blood ethanol concentrations It should not be forgotten that one of the most important reasons leading to hospitalization of children is trauma. Ethanol use is linked to a 3 to 7-fold increased risk of trauma. ”
” ATTENTION TO THE AMOUNT OF ETHANOL IN HERBAL PRODUCTS ”
Atamer warns that herbal products may cause an increase in the risk of organ toxicities, cancer, allergies and autoimmune diseases in children, and if the ethanol concentration in the blood exceeds 2 percent, coma, hypoglycemia, convulsion and low potassium; He stated that if it is between 3-4 percent, disorders such as central nervous system depression, cerebral edema, hypothermia, respiratory depression and hypoxia may occur.
Underlining the issue that the pediatric use of herbal medicinal products containing ethanol should not cause ethanol concentrations in the blood to affect attention and motor coordination, Atamer said that it is unrealistic to expect studies in which safety thresholds for ethanol content in herbal medicinal products for pediatric use have been directly proven.
Stating that the evaluation should be based on other bases, Atamer continued as follows;
“For herbal combinations or concomitant drugs likely to be used in the pediatric population, interactions should be considered. Concomitant use of other medicinal products containing ethanol should be avoided. The dosage interval should be kept as long as possible, the interval should be at least 4 hours to avoid accumulation. When the ethanol concentration in the blood is above 0.125 g / L, detrimental impairment of psychomotor functions may occur. Therefore, the recommendation is that the blood ethanol concentration of 0.125 g / L should not be exceeded after a single ethanol-containing herbal medicinal product. Care should be taken to pack herbal medicinal products containing more than 30 g of ethanol in small volumes with child-proof caps. “
‘SHOULD NOT BE USED IN BABIES UNDER 2 YEARS OLD’
Emphasizing that the information on the ethanol content of the herbal medicinal product should be given clearly and clearly in the instructions for use, Prof. Dr. Atamer stated that ethanol can cause a disulfiram-like reaction, for example in the presence of certain antibacterials. Stating that the treatment period with herbal products should be as short as possible for these reasons, Atamer said, “All herbal medicinal products containing ethanol should not be used in newborns and infants under 2 years of age. It may cause drowsiness, behavioral changes and impairment in the ability to concentrate and participate in school activities in children aged 6 and under. Ethanol administration to children should be minimized and the benefit / risk ratio should be evaluated considering the target population. ” used the expressions.