Adults and children have been advised by the medical community that MiraLax is a safe, over-the-counter remedy for constipation. As it turns out, MiraLax may have or degrade into some of the same toxins found in anti-freeze and thousands of adverse event reports have been filed with the FDA over the course of the last decade.
MiraLax is only approved as a treatment for short-term constipation in adults. Generally recommended for use in adults for up to seven days, it is not approved by the FDA to treat chronic long-term constipation, despite MiraLax being pediatricians’ go-to remedy to fight constipation in children.
Cases are being investigated across the country to hold the manufacturers of MirLax accountable for neuropsychiatric and behavioral side effects associated with MiraLax and potentially other toxic responses. If your child or someone you love has suffered severe side effects from taking MiraLax, Pogust Millrood may be able to help. Our mission is to protect those who are injured by the negligence or misconduct of others – including pharmaceutical companies. You can reach our attorneys online or by calling: 1-888-348-6787.
ACTION NEWS INVESTIGATION: MORE FAMILIES SPEAK OUT OVER MIRALAX SIDE EFFECTS FOR KIDS
“We should not be using something off label that’s not approved in children. I definitely have a great concern over that,” Berry said.
CHOP wouldn’t talk about the $325,000 study they are conducting for the FDA, which was commissioned back in 2014. But to our surprise, apparently it hasn’t started yet. After our report, they published a statement online, which says, “Researchers…have not begun enrolling children, but once enrollment begins, an announcement will be made.”
“To me, there is definitely what I would call a red flag,” civil attorney Derek Braslow told Action News.
Braslow says he is now reviewing more than 500 families’ claims and is considering filing a lawsuit against Bayer, the maker of MiraLAX.
“The manufacturer has a duty to give an adequate and fair warning of what the benefits of the drug are, and what the risks of the drug are and if they are not doing that then they are liable,” Braslow said.
Who is Most At-Risk for MiraLax Side Effects?
Since 2000, there have been thousands of complaints to the FDA related to Polyethylene Glycol 3350 (“PEG 3350”). Concerns remain for the potential of ethylene glycol to be absorbed into a child’s body, the same toxic chemical found in anti-freeze. There are two groups of patients who are most at-risk for the serious side effects from PEG 3350:
a) Adults with Chronic Health Issues: Intended only for short-term use, MiraLax has been known to pose risks for patients who have pre-existing conditions including kidney disease, Crohn’s disease or other chronic medical issues.b) Children: While the MiraLax label is not approved for children, pediatricians have been recommending its long-term use in patients under 17, sometimes with harmful side effects. As reported by the New York Times:
MiraLax labeling notes that it is approved for adults and to take for 7 days, but also to consult with a doctor if under the age of 17 or if it is to be ingested for longer than one week. The old prescription labeling specifically stated it was not to be used in children.
The FDA’s recent actions, in response to a Citizen’s Petition, illustrate that it does not fully understand how MiraLax is processed in the pediatric population. Polyethylene Glycol 3350 (“PEG 3350”) is a petroleum-based toxin made from the antifreeze chemical Ethylene Glycol (EG) and found in MiraLax. PEG 3350 is not easily absorbed in the intestines of adults – apparently making it safe for short-term use – but it may be absorbed differently in children. There are no long-term safety studies that have evaluated the toxicity of MiraLax in pediatric patients or whether Miralax can contribute to neuropsychiatric side effects.
Prompted by continued reports of serious side effects in younger patients and a Citizen’s Petition, the FDA funded $325,000 for the study of PEG 3350 in the pediatric population. Awarded to the Children’s Hospital of Philadelphia, it is looking into whether the common OTC medication polyethylene glycol 3350 (MiraLAX) is sickening children younger than 17 years of age.
Side Effects: MiraLax & Children
The FDA has received thousands of reported side effects associated with the use of MiraLax in patients under 17 years old, including three reported fatalities. These side effects may be associated with ethylene glycol (EG) toxicity and have been reported in pediatric patients with MiraLax use:
- Seizures, Tremors and Tics
- Anxiety, Lethargy
- Aggression, Paranoia, Mood Swings
- Obsessive-Compulsive Behavior
- Metabolic Acidosis
- and others…
Severe Malnutrition-Related Disorders: Because PEG is an osmotic laxative it can block the absorption of nutrients in the intestines. When used in children or older adults for a prolonged time, MiraLax can cause nutritional deficiencies.
Urticaria: Commonly called “hives”, PEG 3350 is associated with allergic reactions including potentially fatal anaphylaxis.
Nephrotic Syndrome: A kidney disorder that causes the body to excrete too much protein in urine due to damage to the kidney blood vessels.
MiraLax in Adult Patients
MiraLax is intended only for short-term use (no more than 7 days) in adult patients, however Merck, and now Bayer, were clearly aware that medical professionals considered and continue to recommend MiraLax as a first-line treatment for pediatric use.
MiraLax is contraindicated for patients with kidney disease because of the toxicity risk of PEG 3350. In this patient population MiraLax has been associated with nephrotoxicity (kidney damage), oxalate nephropathy, renal failure… side effects which could be fatal.
Do Other Laxatives Pose these Risks?
The concerns and warnings associated with MiraLax may also apply to other laxatives that include Polyethylene Glycol 3350. This includes: 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 others.
Has someone in your family been harmed by MiraLax?
Pogust Millrood is a plaintiffs’ law firm focusing on fighting for the rights of patients harmed by dangerous drugs. We are currently investigating claims of side effects from MiraLax. A lawsuit can provide monetary damages for patients and their families to compensate for:
- The expense of emergency visits, medical treatment and ongoing care
- Lost income
- Emotional distress caused by a loved one’s suffering
- Funeral expenses.
Pogust Millrood has a track record of successfully litigating against the manufacturers and marketers of dangerous drugs. If you or your loved one was harmed by MiraLax, let us seek justice for you. For a free consultation, contact us online or call 1-888-348-6787.