Thursday, January 8, 2015
The New York Times: Scrutiny for Laxatives as a Childhood Remedy
“Every pediatric GI physician, I would guarantee you, has told a family this is a safe product,” said Dr. Kent C. Williams, a gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio. Now, he worries, “it may not be true.”
Also, shared on the Today Show
From my previous posts:
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.”
Or how about some antifreeze with that?
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.”
So when your Dr. says something he prescribes is "perfectly safe" is it really?
The big question is, why so many pill popping, Miralax dependent toddlers out there? That is the big question.
Go to any Walmart, Walgreen's,Costco you will see they now sell massive gallon jug like bottles of this stuff.
Ask yourself, why aren't you able to poop?
Posted by Diane at 1:23 PM