Why MiraLAX® is Bad for Autistic Patients

One of our parents was recently told by their child’s gastroenterologist, “I don’t care what the autism doctor thinks (about weaning the child’s dose of polyethylene glycol 3350), I’m concerned about fixing his constipation.” The toddler has speech delay, stims, repetitive behaviors, and doesn’t play with other children. Is it impossible for such professionals to make some connection between G-I problems and autism? Miralax is not a medical workup.

“It’s a drug we use long-term; it’s very effective, has a good safety profile,” said Dr. Samuel Nurko, the director of a center for gastrointestinal disorders at Children’s Hospital Boston. “I’m comfortable prescribing it even though it’s not F.D.A.-approved for children.” (Dr. Nurko has done research partially supported by the former maker of Miralax.)*

An authority. In one sentence he has totally dismissed all the weaknesses that doctors like him proclaim in order to criticize complementary and alternative treatments. Except that there is a great deal more evidence to support our positions than the claims made by MiraLAX’s manufacturers. And I’m not getting paid by probiotic companies (a better way to treat G-I problems in small children).

The label states that the drug should be administered for only short-term and occasional use – a week or so. Many doctors give it for years with no apparent problems. Except that if you don’t think that delayed neurologic development is related to gut abnormalities, you wouldn’t notice the problem. The rise in MiraLAX’ use has paralleled the rise in autism, and that deserves further study; as does the increase in many other potentially toxic substances, such as antibiotics and steroids.

Is there anything better for significant constipation? It is so effective that it caught on quickly as a way to cleanse the gut for endoscopic examinations, then for treating all kinds of constipation, for longer periods of time, and eventually in children. Then, it was approved for over-the-counter short-term use, and still not tested in children. Now, the respected medical advice is that it’s perfectly OK, even though the FDA has issued warnings about claims and safety.

Of course, the better route is to perform an appropriate workup on any patient who has multi-system involvement. The WHOLE patient. That is not what I witness in my daily practice. I often interview families who have never even had a blood count, let alone thyroid function,vitamin and mineral levels, or liver and kidney function testing.  Autistic children deserve a proper evaluation, but the lack of language and altered sensory perceptions in the patient dictate that the practitioner must search for underlying illness.

Those same professionals who give Miralax literally like water would probably say that all of this ‘leaky gut’ stuff is unproven and poorly documented. I see sick intestinal health in practice every day. If the junctions between cells that are supposed to be tight have become damaged and swollen, chemicals may not remain local to the intestines. Polyethylene glycol 3550 might be leaking into some kids’ blood, liver, kidneys and brains. Long-term use could cause significant changes in gut flora and allow viruses and fungi to proliferate. Vitamin absorption in the gut might change. It isn’t difficult to imagine many of the features that we assign to autism as downstream difficulties that get exacerbated by the chronic use of MiraLAX.

I’m often asked whether a child will become addicted to some medicine or supplement. Given long-term, increasing dosages of MiraLAX may be required and the patient will suffer symptoms if the chemical is withdrawn. In other words, the child will get “addicted” to the drug.  WebMD reports that  “Extended use or overuse may result in dependence on laxatives and chronic constipation. Overuse may cause diarrhea, excess loss of body water, and mineral imbalance.”

At best, Miralax presents reasonable short term relief. It is a bandaid that often obscures the treating physician to the real difficulty. At worst, it could be a significant player in a vicious cycle leading to signs and symptoms in some children who appear to have ASD.

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4 Responses to “Why MiraLAX® is Bad for Autistic Patients”

  1. Anne W says:

    Dr. Udell,
    Thank you for your contributions. As a nurse for over 34 years I speak with mothers of autistic children who have sometimes been prescribed Miralax for six to eight years. They cry when I read this list of side effects outlined in the petition against Miralax submitted in June of 2012.
    In December 2012 the FDA warned of reports of possible neuropsychiatric events.
    When will the madness of Big Pharma stop?

    MIRALAX SIDE EFFECTS 
    reported to the FDA and/or miralax@yahoogroups.com
    by parents of children who were given Miralax

    (limited list-more side effects reported since compiled)

    Anxiety
    Phobias
    Extreme nervousness
    Obsessive-Compulsive behavior
    Scratching, biting (self and others)
    Nightmares
    Hysteria
    Memory loss
    Sleeplessness
    Irritability
    Mood swings
    Bipolar disorder
    Withdrawal
    Communication loss
    Loss of concentration
    Vertigo while lying down
    Anger
    Tantrums
    Metabolic acidosis
    Clawing sister’s eyes 
    Sensitivity to sound
    Motor skills affected
    Fearfulness
    Confusion
    Inability to focus
    Mumbled speech
    Gait disturbances
    Obsessive finger licking
    Feelings of something dripping down face
    Compulsive bad thoughts
    ‘Meltdowns’ over homework
    ‘Meltdowns’ over trivial things
    ‘Panic’ behavior
    ‘Dr. Jekyll & Mr. Hyde behaviors
    ‘Wave pool feeling’ when trying to go sleep
    Tics
    Tremors

    Seizures:
    life threatening with 3 fatal cases documented and more suspected

    Violent behavior
    Suicidal thoughts (age 6)
    Paranoia/bizarre hiding
    Anti-social behavior
    Slurred speech, whispering
    Staring 
    Skin disorders
    Keratosis pilaris – chicken skin, what appears to be Miralax particles trying to exit the body through the skin, primarily on the arms and legs

    Homicidal ideation
    Homicide by a fourteen year old boy, completely out of character, but given high doses of Miralax

    This is a short list, there are many others have symptoms that have been reported.

    Call 1-800-FDA-1088

  2. KSmith says:

    I am an adult with Aspergers. I had horrible reactions to Miralax – Dizziness, Anxiety, Mood changes (and I’m stable), Nightmares, Fatigue, to name a few. Then I came across this page and was validated. I am not taking Miralax ever again!

  3. September 2014 – Due to serious safety concerns raised in an FDA Citizen Petition filed by consumer group, Empire State Consumer Project (ESCP), the US Food and Drug Administration (FDA) agreed to study the effects of polyethylene glycol 3350 (PEG 3350) laxative use in children and issued a grant to the Children’s Hospital of Philadelphia to conduct the study. 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.

    Resources

    Empire State Consumer Project FDA Citizen Petition and FDA Response
    http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2012-P-0566;fp=true;ns=true

    NIH Grant to Study PEG 3350 and Test of 8 Lots
    http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-14-088.html

    Empire State Consumer Project and Reply to FDA Petition Response
    http://www.empirestateconsumerproject.blogspot.com

  4. Mike Koehler says:

    Great article…..kudos to you for speaking the truth!!

    I have been monitoring the adverse events filed with the FDA;

    Feb 2015 – 9,073 cases
    Sept 2015 – 10,909 cases or an increase of 1,836
    Oct 2015 – 11,570 +661 from Sept and +2497 from Feb.

    Please consider voicing your opinions & concerns to the FDA. It’s easily done on their website, here’s a great article by TMR explaining the reporting process at thinkingmomsrevolution.com then reporting-adverse-reactions-vaers-and-faers/!!

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