WARNING: the foods we cook for Abby are safe for her, but not necessarily for everyone. Please confirm any ingredients are safe for you before using in your diet. Food Allergies can kill and the best policy is complete avoidance. Read this post for more info.

Monday, August 4, 2014

ALERT: PEG(active ingredient in Miralax) FDA and reports of Neurological and Psychiatric Events.

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.[1] DEG is a widely used solvent.[2] It can be a contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century.[1]


Anonymous said...

I think that the key is the inability of certain individuals (especially people on the autism spectrum) to tolerate oxalates. PEG may be converted into oxalates with the help of microbes in the body.

Diane said...

Great point! I know lots with Mast and Autism and Mito really struggle with oxalates. Abby is good with oxalates though and she had such a nasty reaction to the stuff- was terrifying for us. So I suspect there are probably multiple reasons this is causing such a nightmare for some patients.

Anonymous said...

Testing determined that my daughter had high oxalate levels. My husband, daughter, and I all went on a low oxalate diet to make it easier on our daughter...

After about a year, we discovered that I my kidney stones had disintegrated, my husband's huge staghorn calculi (kidney stone) that had completely filled the open area of his kidney was almost gone, and my daughter's behavior problems, school problems, frustration tolerance, and social issues were much better.

Sufficient dietary intake of magnesium and citrate inhibits the formation of calcium oxalate and calcium phosphate stones, so if these children are low in magnesium and citrate, they will probably be more likely to suffer issues from oxalate consumption. I know my daughter had low magnesium.

Diane said...

That is amazing! I wish more people knew about oxalates. beyond oxalates, I think everyone in America needs more magnesium. It really can help the body process other essentials better, better digestion, better sleep, less muscle pain. Thanks again for the comments! I know a couple folks with major kidney stone issues and I have been begging them to go low oxalate, I will make sure to share your comments with them :-)

Reagan Leigh said...

I took Reagan off Miralax years ago when I heard from other parents that it was causing neurological twitches in their children! (Reagan has enough neurological issues...one of which was persistent twitches!) We haven't used it since (but that hasn't stopped drs from pushing it)!

Diane said...

Drs do pimp miralax big time. I still remember being told, " Oh it is perfectly safe, best one on the market"... then when Abby got so sick no one believed it was the Miralax- ugh. I hope Drs. stop pushing it, or the FDA at least requires labeling with warnings.. If I remember right, they never even tested it in the pediatric population before releasing it over the counter for pediatric use. sigh. Glad Reagan isn't on it! Today someone asked about what to take instead and I remember you posted about milk of magnesia. Miralax is a banned substance in our house.

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