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PP-2 Ethanol content in registered paediatric preparations: address the excess
  1. Berlin1,
  2. Shaniv1,
  3. Mendelson Mastey2,
  4. Ainbinder2,
  5. Schwartzberg2,
  6. Berkovitch1
  1. 1Assaf Harofeh Medical Centre, ZERIFIN, Israel
  2. 2Drug Registration Department, Pharmaceutical Division, Ministry of Health, JERUSALEM, Israel

Abstract

Background Ethanol is commonly used in many pe-diatric liquid formulations as a solvent or preservative, with concentrations varying widely between products per formulation design. Therefore, acute or chronic use of certain products in paediatric patients may expose them to excessive amounts of ethanol. Both the U.S. Food and Drug Administration (FDA) and the Europe-an Medicines Agency (EMA) recommend to exclude ethanol from medicinal products intended for use in children whenever possible. If deemed necessary, however, the FDA has set (1995) a maximum quantity of ethanol content in over-the-counter (OTC) pediat-ric formulations for different ages. Recently (2014), the EMA suggested to lower the ethanol content limit set previously (2006). The use of ethanol in paediatric for-mulations is being evaluated these days by the Israeli Drug Registration Department and new regulations regarding limitations of ethanol content in liquid pediatric formulations (both OTC and prescription drugs) are being finalised. The objective of our study was to com-pile a list of oral liquid paediatric formulations registered in Israel that contain ethanol, and identify products whose ethanol concentration may produce dangerous ethanol blood levels in infants, either by taking the recommended dosage or by accidental consumption of large amounts of the preparation.

Methods The Israeli Drug Registry was searched using the following keywords: elixir, solution, syrup, suspension, drops, tincture and ethanol, and the results were sent to the Drug Registration Department to provide the exact amounts of ethanol in each product per manufacturer’s data. Thirty-nine registered products were identified, of which 29 are currently registered for paediatric use. The majority of formulations are indicated for the treatment of cold and cough symptoms (n=14). Other formulations include antihistaminic, antiemetic and sedative prepara-tions (n=6); analgesics and antipyretics (n=3); antibiotics and anti-epileptics.

Results The preparations were found to differ widely in ethanol content, ranging from <1% v/v to 66.4% v/v. The majority of products (n=28) contain 1%–20% v/v of ethanol, 2 products contain 20%–50% v/v of ethanol, and 1 product contains a very high concentration of ethanol (66.4% v/v). Most of the paediatric products are not ex-pected to produce ethanol blood levels that exceed the upper limit allowed (25 mg/dL) following administration of the recommended dose. However, for a 2-year-old child weighing 12 kg (on average), an accidental intake of an entire bottle of such medications may result in much higher ethanol blood levels, which may reach the toxic ethanol blood level of 50 mg/dL and even higher.

Conclusion Ethanol consumption is strongly discour-aged during pregnancy and lactation, whereas children are constantly at risk for exposure to ethanol through routine use of registered medications. Many paediatricians and parents acknowledge the harmful effect of ethanol in this young population, but are unaware of the high potential for exposure. More than half (n=26) of the available products that contain alcohol do not meet the require-ments set by the new Israeli regulations and would be subject to changes accordingly (either in total volume or alcohol content of the formulation).

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