Miralax is only safe for up to 7 days in an adult, but it is often given to kids for years. The main ingredient Polyethylene Glycol (PEG 3350) is similar to antifreeze and it is linked to seizures, behavior problems, and neurological disorders.
Need a Texas Miralax Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If your child was diagnosed with side effects of Miralax, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is Miralax?
Miralax is a laxative medication that was introduced in 1999 by Braintree Laboratories. In 2006, Miralax was approved by the FDA as an over-the-counter drug. It is now marketed by Merck & Co., Inc.
Who Can Take Miralax?
Miralax is only safe for short-term use (up to 7 days) by adults over 17 years old with occasional constipation — not chronic constipation — at a maximum dose of 17g once a day. Do not use Miralax if you have kidney disease, except under the advice and supervision of a doctor. Ask a doctor for use in children under 16 years old.
What is in Miralax?
MiraLAX contains Polyethylene Glycol 3350, which is an osmotic laxative that pulls water from the body into the intestines to soften stools, stimulate bowel movements, and relieve constipation.
What is PEG 3350?
PEG 3350 is a petroleum-based chemical that is made from the toxic antifreeze chemical Ethylene Glycol (EG), but they are absorbed very differently in the body. Unlike EG, the intestines are bad at absorbing PEG 3350, so not much gets into the bloodstream or kidneys. Miralax is relatively safe for short-term occasional use by adults — unlike antifreeze, which can cause kidney failure or death in 24 hours.
Is Miralax Safe for Children?
Miralax is NOT approved for children or long-term use in anyone. There are no studies of Miralax side effects in children, so no one knows if it is safe. Do not assume Miralax is safe because it is sold over-the-counter. The greatest concern is young children with serious intestinal diseases who take Miralax for years.
What Your Doctor Tells You… and Doesn’t Tell You
Doctors might tell parents Miralax is safe because it is minimally absorbed by adults — but no one knows how Miralax is absorbed by a child, especially infants with ongoing intestinal problems. Their irritated intestines may be less resistant to Miralax, which could increase the amount of Miralax that gets into the bloodstream.
Miralax Dose for Babies & Toddlers
Doctors commonly tell parents to give infants or toddlers a “baby dose” of Miralax, or start with a teaspoon and adjust the dose as needed. They may even say it is impossible to overdose, which is not true. Miralax overdoses can be fatal in any patient, but younger children are more vulnerable to the effects of toxins.
Is Miralax All-Natural?
Doctors also tell parents that Miralax is “all-natural,” which is true if you consider petro-chemicals to be natural. The powder in Miralax looks like white, waxy flakes. This same powder is marketed as CARBOWAX™ by Dow Chemical in a variety of forms, including plastic, which most people do not consider natural.
If Miralax Isn’t Absorbed, Why Are Kids Sick?
Children might absorb more Miralax than adults, but no one knows. Younger children naturally have softer intestines than adults. Chronic constipation can stretch out the intestines, making them even more porous, which is why “Leaky Gut Syndrome” (intestinal permeability) is so common in people with long-term digestive issues. It also explains how kids could get sick from Miralax, and raises concerns about it sitting in their intestines for a few days.
Thousands of Miralax Side Effects Reported
The FDA received 2,257 reports of side effects from Polyethylene Glycol (PEG) between November 2000 and March 2012. These reports included serious kidney, urinary, bowel, blood, skin, and neuropsychiatric symptoms, and at least three child fatalities.
In response to these reports, the FDA Drug Safety Oversight Board held a meeting in June 2009. No action was taken, but the experts warned:
“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.”
Miralax and Metabolic Acidosis
The FDA board-members also discussed metabolic acidosis, a condition involving too much acid in the blood that can cause shock or death. Metabolic acidosis can also be a mild ongoing problem. Miralax was specifically linked to “high anion gap metabolic acidosis,” a type commonly caused by antifreeze or Ethylene Glycol (EG) toxicity.
FDA Investigation Ends — No Miralax Warnings
The FDA Miralax investigation ended in August 2011. The agency rejected warnings for Miralax, recalls, or label updates. Neurological and psychiatric side effects of Miralax are listed as a “potential safety issue” on the website.
Citizens Demand Miralax Recall & FDA Warnings
In 2012, a consumer group in New York filed a Citizens Petition (PDF) with the FDA to re-open the safety investigation, immediately recall Miralax, and add a “Black Box” warning against its use in children.
Two years later, the NIH and FDA awarded a $325,000 grant to the Children’s Hospital in Philadelphia to investigate how PEG laxatives are absorbed by children — including young children with chronic constipation — and possible behavioral or psychiatric effects.
Miralax Tests Positive for Antifreeze Toxins
The FDA tested 8 batches of Miralax in 2008 after patients reported “classic symptoms of ethylene glycol ingestion” — symptoms of antifreeze poisoning — and all 8 batches had low levels of the antifreeze chemicals Ethylene Glycol (EG) and Diethylene Glycol (DEG) as impurities left over from making Polyethylene Glycol (PEG 3350). These test results were not released for several years.
Antifreeze Toxins Not Detected in PEG Laxatives
The FDA tested PEG laxatives from 5 different manufacturers in 2013, but EG and DEG were not detectable. FDA spokesman Jeff Ventura told the New York Times, “The amounts were so low,” and “complied with internationally recognized safety standards.” No one knows if small amounts of EG or DEG in laxatives (or as byproducts of the body metabolizing PEG 3350) might harm children, especially those who take laxatives for years.
Symptoms of Antifreeze Poisoning
The symptoms of ethylene glycol toxicity may include seizures, coma, kidney failure, brain damage, coma, nausea, vomiting, cardiac arrest, blurry vision, blindness, fast breathing, no breathing, loss of balance, and death.
Possible Miralax Side Effects in Children
- Obsessive-compulsive behaviors
- Repetitive chewing and sucking
- Mood swings
- Metabolic acidosis
- And more
In April 2015, a Miralax lawsuit (PDF) was filed by Samuel Woniewala, a man from Pennsylvania who developed serous kidney problems. He took Miralax from 2009 until 2013, when he was hospitalized with oxalate nephropathy — allegedly due to PEG 3350. The lawsuit was filed in the Philadelphia County Court of Common Pleas — In RE: Woniewala v. Merck & Co. et al —Case No. 150402370.
Miralax Kidney Side Effects
- Kidney damage
- Acute kidney injury
- Kidney failure
- End-stage renal disease (ESRD)
- Oxalate nephropathy
- Kidney transplant
Why Do Kids Get Constipated?
Constipation involves 3 or fewer bowel movements per week. The stools are large, hard, and painful to pass. Constipation in children is often due to stress, dehydration, dietary problems, or toilet training.
What Causes Chronic Constipation?
Everyone gets constipated once in a while, but chronic (long-term) constipation is not normal. In some cases, it is caused by underlying problems, for example:
- Medication side effects
- Food allergy
- Crohn’s disease
- Celiac disease (gluten allergy)
- Low thyroid disease (hypothyroidism)
- Cystic Fibrosis
- Hirschsprung’s disease
- Congenital Megacolon
- Birth defects
Need a Miralax Lawyer in Texas?
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Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Miralax lawyers for a free lawsuit review.