IS MIRALAX THE NEXT VIOXX?
Getting mad or forgetful after taking a laxative? Well, according to the US Food and Drug Administration that’s exactly what certain best-selling laxatives can do to you.
Back in December of 2011, the FDA placed MiraLAX —
a polyethylene glycol-containing blockbuster drug marketed by Merck & Co
— on its Adverse Event Reporting System (AERS) in connection to
Besides MiraLAX, this warning also applies to Movicol, Dulcolax, Colyte, Colovage, Co-Lav, Clensz-Lyte, ClearLax, GoLYTELY, GaviLyte C,
GlycoLax, Go-Evac, GlycoPrep, E-Z-Em Fortrans, Halflytely, Lax-a-Day, LaxLyte, MoviPrep,
Macrogol, NuLytely, OCL, Peg-Lyte, Prep Lyte, Softlax, TriLyte, and all other brands with Polyethylene Glycol
3350 (PEG for short) as their active ingredient. The “3350” qualifier refers to the
molecular weight of this particular variant of PEG.
The cutout from the MiraLAX-related posting on the FDA's website .
Polyethylene glycol is made
by stringing together molecules of ethylene glycol into a large polymer
chain, hence the
prefix poly-, Greek for many. On its own, ethylene glycol is used in
automotive antifreeze and brake fluid. According to the National
Institute for Occupational Safety and Health, it is an extremely toxic
“Ethylene glycol is
chemically broken down in the body into toxic compounds. It and its
toxic byproducts first affect the central nervous system (CNS), then the
heart, and finally the kidneys. Ingestion of sufficient amounts [as little as 30 ml — KM] can be
The term “neuropsychiatric events” in the FDA's
safety alert refers to neurologic disorders of the central and
peripheral nervous systems
such as autism, dementia, depression, schizophrenia, multiple sclerosis,
Alzheimer’s and Parkinson’s diseases, and similar others . These
conditions result from PEG's direct (through cellular damage) and
indirect (through malnutrition of essential micronutrients)
neurotoxicity. No surprise there considering the quotation above.
Lead, mercury, and arsenic are some of
the best known neurotoxins. So are snake venom, curare, botulinum, and tetanus. PEG is more like
lead or mercury — slow-acting, insidious, and
difficult to pin down conclusively
onto a variety of “slow-brewing” neurological disorders.
In addition to neurotoxicity, the following serious
complications have been associated with polyethylene glycol-containing
● Nephrotoxicity: PEG has been connected to nephrotoxicity
— an euphemism for kidney damage — when used as a drug solvent [link, link] or when applied to skin . For
these reasons PEG is contraindicated for patients with kidney disease.
This particular “side effect” is most likely related to the hydrolyzed
(separated in water solution) molecules of ethylene glycol.
● Urticaria: PEG may cause allergy-related hives (urticaria) — raised red welts on
the surface of the skin. Children are particularly susceptible to
hives, and face a grave risk of anaphylaxis — a life-threatening
allergic reaction that may develop within minutes or even seconds after
ingesting a PEG-containing laxative. Links between PEG and urticaria
have been documented as far back as 1991 [link].
● Esophageal perforations: Also known as Mallory-Weiss tear,
associated with polyethylene glycol electrolyte lavage solution have
been reported as far back as 1991. These tears and related
bleedings may occur in the mucus membrane of the lower part of the
esophagus, or upper part of the stomach [link].
This particular side effect
isn't directly related to MiraLAX which is taken in smaller doses, but
the potential is always there, particularly among young children or
patients with GI tract obstruction that may initially manifest itself as
● Encopresis. The involuntary passage of stools in toilet
trained children is one of the nastiest side effects of taking
PEG-containing laxatives. The same condition may affect adults, and for
the same reasons — a continuous leakage of semi-formed stools from the
large intestine, an outcome of PEG “working” too well.
All of the “collateral
damage” from PEG shouldn't surprise anyone, least of all seasoned chemists,
pharmacists, and medical doctors. This industrial chemical is
manufactured by The Dow Chemical Company for use in wood treatments, paints,
coatings, rubber, textiles, detergents, and toilet bowl cleaners .
The stock (© iStockphoto
LP) illustration from the cover page of the Carbowax™ product brochure by The Dow Chemical Company, a leading manufacturer of industrial PEGs.
Technically, PEG is an osmotic laxative.
Because of this property, it blocks the absorption of nutrients in the small intestine.
extended use may result in severe malnutrition-related disorders,
particularly in young children and older adults. Autism is one such disorder. It
may take only two weeks of an acute iron or iodine deficiency to cause
autism in a child younger than two.
The same properties of PEG that make it an
excellent toilet bowl cleaner, also wipe clean the mucosal membrane of the
large intestine, leaving the colon unprotected and cancer-prone, a
situation similar to a dry mouth. On top of the mucosal membrane damage, a high osmotic gradient of
polyethylene glycol solution decimates intestinal bacteria — single
cell organisms — just as mercilessly as antibacterial soaps,
antibiotics, or heavy metals.
The resulting dearth of intestinal bacteria is called dysbiosis
in the United States, and disbacteriosis in the rest of the world.
Dysbiosis reduces primary immunity,
causes a broad range of neurological and blood disorders, makes
occasional constipation chronic and more severe, ensures lifelong dependence on laxatives, and is behind
ulcerative colitis, Crohn’s disease, and colorectal cancer.
Disbiosis is also behind premature aging, which is
self-evident in the early graying of the hairs, type 2 diabetes, facial
wrinkles, patchy skin, weak nails, tooth loss, arthritis, and
osteoporosis. These particular pathologies may be related to the
deficiency of biotin (vitamin H) and vitamin K, which are, under normal
circumstances, synthesized by the healthy intestinal flora. The PEG's
blocking effect on the absorption of vitamins and minerals in the small
and large intestine also plays a role.
When PEG is combined with a high fiber diet — a standard
remedy for dysbiosis — problems double up because indigestible fiber
tends to enlarge stools. In turn, large stools lead to habitual
straining — a primary cause of enlarged hemorrhoids, anorectal nerve
damage, anal fissures, diverticular disease, fecal obstruction, and
genitourinary disorders such as rectocele — a protrusion of the
rectovaginal wall inside the vagina.
A single recommended dose of MiraLAX contains 17 grams
of pharmaceutical grade PEG powder
, a humongous amount of what is otherwise an
industrial-strength anti-fungicide, insecticide, and germicide strong enough to preserve wood beams,
railroad ties, and
electrical poles from
fungi, insects, and bacteria practically forever. It works by displacing water in wood, which makes
it resistant to
warping and rotting.
This is kind of ironic — the same people who will go
out of their way to “eat organic” in order to avoid traces — we are talking micrograms — of fungicides, insecticides, and
germicides in their foods, will then go on and ingest a heaping tablespoon of
polyethylene glycol-containing laxative without blinking an eye. Or give
it to their children...
Despite all of its well-established risks, MiraLAX has never been
tested for safety in pregnant women and children:
“Safety and effectiveness [of PEG] in pediatric patients has not been established. ”
“Animal reproductive studies have not been performed with Polyethylene Glycol
3350 NF. It is also not known whether Polyethylene Glycol 3350 NF can
cause fetal harm when administered to a pregnant woman, or can affect
reproductive capacity...” 
For these and other prudent reasons MiraLAX was approved by the Food
and Drug Administration back in 1999 only for use by adults, and for no
longer than 7 days. In spite of this clear and
unambiguous rule, pediatricians routinely prescribe
PEG-containing laxatives to children of all ages
 anyway. Equally
disturbing, many doctors encourage adults and children alike to
take them indefinitely, even though the label clearly states: “Use no
more than 7 days.”
The cutout from the MiraLAX product label .
A citizen petition “To Investigate Polyethylene Glycol
3350 Product Safety for Use with Pediatric Patients” was filed with the
U.S. Federal Drug Administration on June 6, 2012. Here is what it said:
“As of March 2012, the FDA Adverse Event Reporting
System showed 2257 reported adverse events related (in any way) to PEG
products - up from 7 in 2001. Included in the adverse events
reported are serious kidney, urinary, bowel, blood, skin, and
neuropsychiatric symptoms - and at least 3 children's deaths. [PDF
Keep in mind that only a tiny percentage — around 1% —
of serious side effects ever get reported to the FDA [link].
It's probably even less with MiraLAX and its clones — unlike with prescription drugs, making direct connections with
PEG side effects is
far more challenging because so many of them aren't
immediate; or because nobody expects to encounter severe complications from a “mere”
over-the-counter laxative; or
because small children can't communicate their sufferings in words; or because
it's so hard to identify whodunit among adults who are
already taking a daily cocktail of other potent drugs; or because these
outcomes are falsely blamed on genetics, environment, and old age.
The use of laxatives is particularly common throughout
pregnancy. It’s entirely possible that ethylene glycol molecules
penetrate the placenta and cause neurological damage in fetuses. Infants
may be equally affected via breast milk, or milk supply may be poor
quality or too low.
And that's on top of the maternal malnutrition and neurological damages I've
Notably, MiraLAX was introduced back in 1999
, about the same time the epidemic of autism began sweeping across the
United States in earnest. It doesn’t take a PhD in epidemiology to infer a
possible connection between these two happenings.
If anyone you know is pregnant
or nursing, please let them know about the possible role of polyethylene
glycol-containing laxatives in autism, postpartum depression, and other neurologic
disorders. The connection between these conditions and MiraLAX
has never been proven conclusively because conducting this kind of
clinical research is illegal. Still, as a lawyer might say, “the preponderance of the evidence
is overwhelming,” so you are better off being safe now than sorry
particularly with something as easily avoidable as PEG-containing
Laxatives with polyethylene glycol are also a potential
menace to seniors who rely on them to alleviate medication-related constipation —
a common side effect of taking multiple prescription drugs for depression,
insomnia, and hypertension.
a link to this page to your parents
and grandparents, so they can protect themselves from memory loss,
dementia, and Alzheimer’s disease made eerily possible by taking polyethylene
Unfortunately, despite all
of the above issues and the FDA’s published warning related to polyethylene glycol safety, you still
won’t find a hint of concern in MirLAX’s patient literature.
All it says: “MiraLAX® is safe and effective – and available without
The cutout from “What Is MiraLAX” product brochure .
How can Merck get away claiming that MiraLAX is
“safe” and “without harsh side effects?” Well, just like it did with
Vioxx, another presumably “safe” miracle drug .
Following this well established pattern, Merck will continue milking
MiraLAX's franchise for as long as it can.
When the time will
finally arrive to
recall it, Merck's army of lawyers will keep fighting its victims until they'll settle en masse for pennies on the dollar . It's a cost of
doing business, nothing personal...
But this ugly story doesn’t end with laxatives. It actually gets even uglier
— food grade polyethylene glycol (under the Carbowax Sentry trade
name) is commonly added to chewing gums, table-top sweeteners, and energy
drinks. It is also used as a base in solid and liquid soaps, shampoos, bath
and shower gels; body and face creams and lotions; toothpastes, ointments and
suppositories; as a tablet binder in drugs and supplements; as a lubricant in vaginal gels
and eye drops; and as a solvent in cough medicines and elixirs. Many of
those products are used by children of all ages .
Stock (© Inmagine, © Corbis/Photosearch) illustrations from the page 5
and page 9 of the Carbowax™ Sentry™ product brochure by
The Dow Chemical Company. Deadly
effective, I must say...
Please alert your family, friends, and colleagues
with young children about
the dangers of polyethylene glycol in their foods and medicines via your
Facebook page, Twitter feed, e-mail, website, or blog.
you think you or anyone under your care was harmed by taking
PEG-containing laxatives, you may report your concerns to the FDA
Safety Information and Adverse Event Reporting Program by following
this link [MedWatch
Voluntary Report for Consumers].
How to wean yourself off
For an in-depth look at all
constipation-related issues, check out the following pages:
» Constipation Unplugged (How to overcome
chronic and intermittent constipation).
Explains the physiology of constipation and irregularity. A must-read
for medical professionals.
» Bull's S..t In The China Shop.
Explains why and how high-fiber diets and fiber laxatives contribute to
chronic constipation. If you think that by accusing everybody's favorite
“health food” of treason, I, somehow, lost my marbles, reading this
instructive page will definitely sober you up.
» Overcoming Fiber Dependence.
PEG action is somewhat similar to the action of soluble fiber. Since
most people who are taking PEG-based laxatives also consume a lot of
fiber, this article is an essential read.
» Restoring Natural Bowel Movements.
If your body is still free of irreversible colorectal damage, you should
be able to do what our ancestors have done for millennia — move bowels
without a second thought or “helping hand” from the likes of MiraLAX.
» Restoring Intestinal Flora.
This page is a must-read for all PEG users unless you don't mind getting
gray hair, a feeble mind, absent memory, tremulous hands, withered skin,
hard-to-stop bleedings, and impaired immunity. (Hint: all of these
conditions are related to compromised intestinal flora.)
» Restoring Anorectal Sensitivity.
A bowel movement is always preceded by the unmistakable urge. If you are
chronically constipated, it means that somewhere along the line you've mastered the
dubious art of urge suppression. This article may help you to un-master
» Frequently Asked
Questions about all kinds of “constipations,” about what to
eat and what not, and assorted myths that get people hooked up on
laxatives for life if you are an optimist, or 'until death' if you are
These are the must-read pages if you are planning to
have a baby, or are raising one already:
» Why Is My Infant Constipated?
» Why Is My Toddler Suddenly Constipated?
» What Are
the Causes Of Constipation In Older Children?
What Is the Connection Between Infant Constipation, Diarrhea, and
Please read these pages before emailing me a teary
"help me" plea. As a medical writer, I can write about these subjects
freely, but I can't help your child directly because doing so over email
is irresponsible, let alone outright illegal for anyone but a
And don't ever forget that the cases of congenital
constipation are extremely rare. If healthy infants develop it, it isn't
their fault, but yours and,
in many cases, of their doctors. If you let this problem fester unresolved
until they “grow out if it,” you and your child may end
up paying a heavy price for it later.
Keep in mind that none of the supplements recommended
on this site are appropriate for infants and children with the exception
of Hydro-C, and along with these
important caveats: Hydro-C for
children. Consult your doctors before giving Hydro-C to your child.
If they plead ignorance or indifference, then ask them the following
"Doctor, knowing what we know
now about MiraLAX, would you prescribe it to your own child?"
This question will definitely get their attention. And
if not, you can always find another doctor.
By pointing out MiraLAX-related risks to medical
professionals, you will not only protect the health and future of your
child, but will also help other children under their care in a similar
Reader's Testimonial “Hi, I have just started using Hydro-C on my 22 month old daughter, she has been constipated since 8 months old. I have noticed that not only has her bowl movements improved greatly, but also her sleep. After the first dose I gave her, she did not poop right away, but slept well that night. She has not slept more than a 2 hour span of sleep at one time since she was 5 months old. Her sleep is broken up all night long, averaging 40 minutes to an hour at a time and I have to put her back to sleep each time she wakes. (For this reason we co-sleep, or I would not get any sleep at all.) She now sleeps a 4 hour stretch, with some smaller ones. I have tried everything for both her sleep and her constipation, everything natural, and unfortunately I did use PEG 3350 at the recommendation of a paediatrician, and nothing has helped in any area. I stumbled across your site when researching what PEG really was (I was told it was just fibre!!) and I thank God that you have informed people about PEG.”R.C., Canada (via e-mail)
If you think this article is a tempest in a teapot, you
have no idea just how insidiously damaging constipation may be to
someone's health, physical and mental alike. And even more so to a
hysterically crying baby with zero tolerance for pain, but no capacity
to describe in words what's hurting her.
Adding insult to injury, after getting nuked with
an abdominal CT scan to “diagnose” constipation and, then hooked on MiraLAX by the
very doctors expected to protect her health, she may end up autistic and cancer-prone for the rest of
All that said, I am not yelling “fire” here for the sake
of making a point. To the contrary — this site provides safe, effective,
solutions for resolving the nastiest kinds of “constipations,” and I hope you'll use them.
If you are interested in exploring connections
between autism and nutritional deficiencies related to PEG, please check
out these articles:
Iodine deficiency as a cause of autism. J Neurol Sci. 2009;276(1-2):202;
author reply 203 [link].
Keleşoğlu FM, Tanıdır C, Cöpür M. Ferritin and iron levels in children
with autistic disorder. Eur J Pediatr. 2012 Jan;171(1):1436 [link].
Even though dysbiosis — the
dearth of intestinal microflora in the large intestine — isn't
recognized in the United States as a medical condition, it doesn't mean that there isn't plenty of
academic research to support its role in countless pathologies:
DeCoffe D, Molcan E, Gibson DL. Diet-induced dysbiosis of the
intestinal microbiota and the effects on immunity and
disease. Nutrients. 2012 Aug;4(8):1095-119 [link].
Zamboni G, Fontana E, Zoccante L, Tatò L.; A case of partial biotinidase
deficiency associated with autism. Child Neuropsychol. 2003
deficiency, The Merck Manual of Diagnosis and Therapy [link].
Israel Deaconess Medical Center [link].
Nguyen-Khoa, MD; Vitamin K Deficiency; Etiology; Medscape Reference [link].
If push comes to shove, don't
fight your doctors over this contentious topic — just refer them
to these links. These references are as mainstream as it gets.
Incidentally, the “Merck” in the Merck Manual is the same “Merck” as in
MiraLAX story. Go figure...
Déjà vu all over again...
On or about May 7, 2014, Merck & Co., Inc. entered into a “definitive agreement” with Bayer AG of Germany to sell their consumer care division — the one behind MiraLAX — for $14.2 billion [link]. This transaction, I believe, is a bad omen for anyone facing chronic constipation, and here is why:
Bayer AG ( €40.2 billion revenue in FY 2013) is the company behind Bayer Aspirin, also known generically as acetylsalicylic acid. Aspirin belongs to a class of non-steroidal anti-inflammatory drugs. It is commonly used to treat pain, high fever, arthritis, inflammation, as well as promoted to reduce the risk of heart attack (more on this later).
Besides plain and coated aspirin, the company sells Bayer Chewable Aspirin. It is available in 81 mg chewable tablets with “pleasant orange or cherry flavor,” and is promoted on the website shamelessly named wonderdrug.com.
The only class of patients who may need a chewable version of aspirin are small children who can't swallow regular tablets. In fact, not so long ago this product has been cheerfully sold as Bayer Children's Chewable Aspirin in 80 mg (1.25 grains) tablets:
As you can see from the illustration above, the doses of aspirin recommended for children were incredibly high:
— Up to 800 mg per day between the ages of 2 and 4 years, or two 80 mg tablets up to five times daily for a total of 10 tablets each day;
— Up to 1,200 mg between 4 and 6 (15 tablets total);
— Up to 1,600 mg between 6 and 9 (20 tablets total);
— Up to 2,000 mg between 9 and 11 (25 tablets total);
— Up to 2,400 mg between 11 and 12, or 30 tablets in a single day.
I wonder how many children had been permanently harmed from these recommendations. I don't know when this product was removed from circulation, but judging from the expiration date on the bottle, this insanity was happening as recently as in 1989.
After an intense pressure from pediatricians and regulators, Bayer took the word “Children's” from the label because aspirin is connected to Reye's syndrome — a sudden brain and liver damage among young children who took aspirin for high fever. For similar reasons, pediatric cold syrups with aspirin were quietly removed from the market in the recent past.
Even adults aren't spared from a similar deception. Bayer AG markets Bayer Safety Coated Aspirin with the implied promise that it is safe for the stomach: “Enteric coating is a delayed-released safety coating that provides added stomach protection,” they say.
In reality, an enteric coating DOESN'T offer any protection because aspirin is a systemic drug, meaning it causes bleedings not because of its contact with the stomach's mucosal membrane, but because it reduces the coagulation of the blood, a frequent cause of death or disability in older adult caused by internal bleedings related to accidental falls, peptic ulcers, vascular ruptures, or hemorrhagic strokes.
Speaking of the prevention of the heart attack and stroke with aspirin:
The composite cutout from the FDA's Consumer Update website,
Article released on
May 5th, 2014 [link].
If you know anyone who takes Bayer Safety Coated Aspirin to prevent a heart attack or stroke, or, God forbid, may be giving Bayer Chewable Aspirin to their young children, please let them know about their potential harm!
To summarize — expect worse. After all, getting back some of that $14.2 billion investment into the Merck's discards, or keeping the sales of the “wonderdrug” afloat, will require a lot of unsuspecting patients, a lot of complacent (or complicit) medical professionals, and a lot of victims.
To prevent this from happening to your relatives, friends, and associates, please share this life-saving information on your Facebook, Twitter, or LinkedIn pages. As improbable as it may sound, your single click today may save more than one life tomorrow. Thank you!
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1. U.S. Food and Drug Administration, “Polyethylene
Glycol (PEG) 3350 over-the-counter oral laxative (Miralax),” Potential Signals of Serious Risks/New Safety Information Identified by
the Adverse Event Reporting System (AERS) between October - December
2011, last modified October 18, 2012, [link].
2. National Institute for
Occupational Safety and Health (NIOSH), "ETHYLENE GLYCOL : Systemic
Agent," The Emergency Response Safety and Health Database, last
reviewed May 12, 2011, accessed January 16, 2013, [link].
3. The Merck Manual for Healthcare
Professionals, "Neurologic Disorders," Accessed January 16, 2013, [link].
4. F. Alan Anderson, "Special
Report: Reproductive and Developmental Toxicity of Ethylene Glycol and
Its Ethers," International Journal of Toxicology, 18, no. 2
(1999): 53-67, [link].
5. Dow Chemical Company, "CARBOWAX™
Polyethylene Glycols: Innovation, Performance, Flexibility and Quality
from the Global Leader in PEGs," published October 2011, [PDF
6. “MiraLAX easily dissolves in
four to eight ounces of water, fruit juice, or any other beverage. And
each 7, 14, and 30 dose bottle top is a measuring device that indicates
one 17g dose.” –MSD Consumer Care, Inc., “How do I take MiraLAX?,”
7. Breckenridge Pharmaceutical
Company, “Polyethylene Glycol,” Drugs.com, last revised January 2012, [link].
8. Catherine Saint Louis, “Drug for
Adults is Popular as Children’s Remedy,” New York Times, May 25, 2012, [link].
use and ask a doctor if you need to use a laxative for longer than 1
week,” MSD Consumer Care, Inc., “Directions,” “Warnings,” MiraLAX
product label, [PDF
10. “In 1999, when the F.D.A.
first approved MiraLAX, the patient materials included the warning:
“MiraLAX should not be used by children.” – Catherine Saint Louis,
“Drug for Adults is Popular as Children’s Remedy,” New York Times, May
25, 2012, [link].
11. Consumer Care, Inc., “What is
MiraLAX?,” MiraLAX Product Brochure, page 2, [PDF file].
12. “Up to 140,000 extra heart
attacks may have been caused in the US by the recently withdrawn drug
Vioxx since its launch in 1999.” –Shaoni Bhattacharya, “Up to
140,000 heart attacks linked to Vioxx,” NewScientist.com, published
January 25, 2005, [link].
13. “Merck settled in late 2007
for a relative pittance, resolving some 50,000 Vioxx cases for just
under $5 billion. It was a far cry from the $25 billion to $50 billion
in liability that analysts had predicted when Merck withdrew the drug.”
–Snigdha Prakash, “The Cover-Up Artist: Why is the CEO of Merck leading
the sex-abuse investigation at Penn State?,” Slate.com, posted November
15, 2011, [link].
14. The Dow Chemical Company, CARBOWAX™
SENTRY™ Polyethylene Glycols: Innovation, Performance, Flexibility and
Compliance from the Global Leader in PEGs,” published October 2011, [[PDF
All references above were compiled in December of 2012. If any of the links
is missing, you can locate it on the Internet