Department of Health and Human Services:
The Use of Polyethylene Glycol in the Pediatric Population (R01)
RFA-FD-14-002: The Use of Polyethylene Glycol in the Pediatric Population (R01)
Center for Drug Evaluation and Research ( CDER ) The Use of Polyethylene Glycol in the Pediatric Population (R01) R01 Research Project Grant New RFA-FD-14-002 None See Section III. 3. Additional Information on Eligibility .
"The Food and Drug Administration has received a number of reports of adverse events in children taking PEG products. The Agency has conducted a review that documented a number of reports of neurological and psychiatric events associated with chronic PEG use in children. A number of these pediatric patients received an adult dose of PEG (17 grams) for a duration ranging from a few days to a couple of years. "
"Whether the PEG contributes in some way to these adverse events is not clear at this time. One possible link between PEG use and adverse events in children is the absorption of LMW species leading to these outcomes. In addition, it may be possible that absorption of PEG in children is greater than in adults, especially in constipated patients. Another possible etiology for these safety concerns is that PEG products may be degraded before ingestion if parents pre-mix the product and store in suspension form for a prolonged period. Finally, some children may be more susceptible to the adverse effects of PEG, especially when high doses are given or after prolonged use."
"To better understand the level of polyethylene glycol impurities in PEG, the FDA Chemistry and Manufacturing group evaluated PEG 3350. This analysis of eight lots of PEG 3350 confirmed the presence of small amounts of ethylene glycol and diethylene glycol in all lots tested. Based upon the recommended daily adult dose of 17 mg daily dose PEG 3350, the maximum daily exposure of ethylene glycol would be 0.005 mg/kg/day for a 60 kg patient, or 0.015 mg/kg/day for a 20 kg pediatric patient (approx 5 years of age). Other low molecular weight PEGs were not included in this analysis. However, it is not known if any of these LMW species are absorbed and if so to what extent. Understanding the human absorption profile of LMW species is the first step needed in trying to understand the possible contribution of PEG 3350 use to the development of adverse events in children using this product chronically."
Ethylene glycol(via Wikipedia): Not to be confused with Propylene glycol or Diethylene glycol.
Ethylene glycol (IUPAC name: ethane-1,2-diol) is an organic compound primarily used as a raw material in the manufacture of polyester fibers and fabric industry, and polyethylene terephthalate resins (PET) used in bottling. A small percent is also used in industrial applications like antifreeze formulations and other industrial products. It is an odorless, colorless, syrupy, sweet-tasting liquid. Ethylene glycol is only weakly toxic, but cases of poisonings are not uncommon. Very small amounts of ingested antifreeze (an ounce or less) can be fatal.
Diethylene Glycol(via Wikipedia):is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent. It can be a contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century.