FOR IMMEDIATE RELEASE
September 22, 2014
Carol Chittenden, Empire State Consumer Project firstname.lastname@example.org 585-831-7124
FDA TO STUDY SAFETY OF ADULT-ONLY LAXATIVES PRESCRIBED TO CHILDREN
Rochester, NY – Due to serious safety concerns raised in an FDA Citizen Petition filed by consumer group, Empire State Consumer Project (ESCP), last week, the US Food and Drug Administration (FDA) agreed to study the effects of polyethylene glycol 3350 (PEG 3350) laxative use in children. The group submitted the petition in 2012 on behalf of parents who say their children have been harmed by polyethylene glycol 3350 drug products. There is special concern about the safety of PEG 3350 laxatives like Miralax, which are not approved for use in children, and are not approved for more than seven days use. Many children are prescribed multiple daily adult doses by doctors off-label, often for months or years at a time. The ESCP petition calls for an investigation into the effects of PEG 3350 on children and a boxed warning on PEG 3350 products. The boxed warning was not granted, but the FDA has decided to update the labeling of prescription PEG 3350 bowel preparations with more stringent warnings and precautions for patients with certain health conditions.
The safety concerns reported in the FDA Citizen Petition are symptoms similar to those of ethylene glycol toxicity. The petition grant includes an agreement by FDA to study the potential for PEG 3350 to degrade into ethylene glycol (EG) and diethylene glycol (DEG), and to study the long term effects of PEG 3350 products on pediatric patients. Ethylene glycol and diethylene glycol are chemicals used to make antifreeze. Both are toxic to the central nervous system, liver, and kidneys when ingested. In recent history, DEG contaminated cough and acetaminophen syrups killed hundreds of adults and children. In 2007, the FDA issued a warning for consumers not to buy toothpaste from China, as some brands were made with DEG.
The FDA Adverse Event Reporting System (FAERS) shows over 7,000 adult and child adverse event reports that include at least one PEG 3350 product, including a number of deaths. The number of reports rose from 2,257 in 2012, when the FDA Citizen petition was filed. In 2009, the FDA Drug Safety Oversight Board acknowledged neuropsychiatric, metabolic, gastrointestinal, and kidney events in children who took PEG 3350 laxatives, but felt that “no action was required” at that time:
“The Drug Safety Oversight Board discussed reports of metabolic acidosis, metabolic acidosis with increased anion gap, and neuropsychiatric adverse events in children using polyethylene glycol (PEG) products. Metabolic acidosis is a disturbance in the body's acid-base balance and causes too much acid in the blood. In some situations, metabolic acidosis can be a mild, chronic condition; however, it may lead to shock or death in severe cases. Neuropsychiatric adverse events may include seizures, tremors, tics, headache, anxiety, lethargy, sedation, aggression, rages, obsessive-compulsive behaviors including repetitive chewing and sucking, paranoia and mood swings.” “It is unknown if prolonged duration in solution would change the chemical properties of PEG-3350, and what the actual content of ethylene glycol or diethylene glycol or other low molecular weight PEG would be under such conditions.”
In addition to the ethylene glycol and diethylene glycol children may be exposed to through the degradation of PEG 3350, the FDA has tested 8 lots of polyethylene glycol 3350 and found ethylene glycol and diethylene glycol contaminants in the product itself:
“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.”
Empire State Consumer Project has since petitioned the FDA to issue a Drug Safety Communication regarding the finding of ethylene glycol and diethylene glycol in all lots of PEG 3350 it tested, so that parents of study participants and all parents can be made aware of the potential for PEG 3350 to contain ethylene glycol and diethylene glycol. This petition for a Drug Safety Communication was denied. The EPA recommends that children not be exposed to more than 20 mg/L or 20 parts per million (ppm) of ethylene glycol in drinking water per one day or 6 mg/L or 6 ppm per day over 10 days. The adult doses of PEG 3350 tested were found to contain 0.3 mg of ethylene glycol of daily exposure for a 44 lb. child. This exposure is in addition to any EG and DEG exposure that may be found to occur from PEG 3350 degradation of the laxative products. The health effects of long term exposure of children to PEG 3350 are not known, although risks from short term exposure to EG and DEG are well documented in humans.
Empire State Consumer Project is a 501c3 registered Not-for-Profit Organization dedicated to reducing the use of chemicals toxic to human and environmental health. We accomplish this by educating consumers and industry, conducting product testing and reporting, and by advocating for regulation where needed to protect the public interest.
Empire State Consumer Project FDA Citizen Petition and FDA Response
NIH Grant to Study PEG 3350 in Pediatric Patients and Test of 8 Lots
Empire State Consumer Project, Inc.