MiraLax Side Effects May Cause Neuropsychiatric Problems In Children, Parents Claim

Irvin Jackson

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A study has been launched to investigate recent reports that suggest the laxative MiraLAX may be causing mental problems among children. 

The Children’s Hospital of Philadelphia (CHOP) is conducting a study to evaluate parents’ claims that MiraLAX side effects can cause anger, aggression, paranoia and other neuropsychiatric problems in pediatric users.

Following a petition by parents, such as the Parents Against MiraLAX (PEG 3350) Facebook group, the FDA and National Institute of Health gave a $325,000 grant to CHOP in 2014 to conduct the study, which is now reportedly underway.

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The study also came after the FDA received at least 167 reports of adverse events regarding children who experienced MiraLAX neuropsychiatric problems.

MiraLAX is a laxative approved by FDA for prescription use in February 1999, and later was approved for over-the-counter use in 2006. However, it is not labeled for pediatric use or for use over extended periods of time. It’s active ingredient is Polyethylene Glycol (PEG) 3350. Some tests have also discovered small amounts of ethylene glycol and diethylene glycol; ingredients found in antifreeze.

To date, the FDA has not placed a label warning on the drug, indicating that there is currently insufficient evidence of a link between PEG 3350 and child psychological problems. However, the agency did agree to fund further research following parents’ complaints, and acknowledges that it is aware that some doctors prescribe MiraLAX to children for long-term use.

Bayer has defended MiraLAX safety, maintaining that previous studies have shown no psychiatric side effects from the drug, and indicating that the amounts of ethylene glycol and diethylene glycol detected were small enough to be well within accepted safety margins. The company also emphasizes that it warns that the drug is not approved for use by children.

There have been no details released about the CHOP study currently underway. The hospital has said it will submit its findings to the FDA when they are completed.

Tags: Bayer, Children, Childrens Drug, Laxative, MiraLAX

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16 Comments

Tracey
My 4 year old has been holding ever since she was potty trained. Was referred to a gastroenterologist who ran a test and then just settled on the fact that she needed Miralax every to get her going regularly. I’m not a fan of medicine and would prefer alternate routes, they seemed to work for awhile but this week after changes in routine due to traveling she went almost a week without going. With nothing else working I turned to Miralax to get her body moving. By night 2 she did go but that evening she had a terrible almost panic disorder meltdown that I had never seen before. My 4 year old is an outgoing, sweet, happy sing songs toddler and I have never seen her get like that before. Will not be using Miralax anymore
Bridget
My micropreemie has been on miralax since newborn. He currently has tingly feet hands , acid reflux, heart pains, kidney pains, abdominal pains, always lashes out his behavior, and needed a cpap machine over the summer and gained 25 lbs miraculously. But no longer needs it. Huh So strange.
Maria
My daughter has been on miralax on and off as prescribed by pediatrician for some years. I didn’t make the connection until now. She has severe aggression, tics, obsessive compulsive behavior, etc. We have had dcf and police involvement, multiple ER visits (inpatient and out patient), hospital refusing to help. She displays jekyl and Hyde behavior. Physically aggressive toward family members, breaking and throwing things, and has kicked down doors. We have to give her psych meds to control the severe aggressions.
Jen
My child is 10 yrs old, she is a twin. She has been on MiraLax off and on since she was little. She has had issues with anger since she was a baby and also has developed issues with anxiety. But as she has gotten older it has gotten worse. When she has her “episodes” she gets very aggressive and angry at her father, her sisters, and myself. She yells, wishes herself or her father and I are dead. Sees monsters and claims they tell her to act this way. Is it possible that being on MiraLax off and on for a period of time can make her issues on dealing with anger and anxiety worse?
Patty
My sons been taking Miramax since the age of 9 months. He’s now 17 Mo ths and I too have reccognixed the behavioral changes in him. He use to be a calm, sweet happy little baby and now hes lashes out in very angry episodes, he use to sleep throughout the night but now wakes up in the middle of the night crying . He also wonders around whinning and crying for no apparent reason and these are changes that ive noticed over the last few months . He’s also having problems with speech and forming words. Im so heartbroken that this was even reccommended by a professional and it was my ignorance for not looking into it . it’s such a dramatic change and I feel like a horrible parent poisoning my son. Are these changes permanent? Someone please get back to me, I’m very concerned
Sara
My little angel turned demon at 3 yrs old when she was placed on Miralax for chronic constipation. She wouldn’t potty train because she was scared to poop because it hurt so bad. She’s 6 now and her anger, mood swings, sociopathic behavior is tearing our family apart. I am just now learning about this after seeing an article on FB. I want more information and would be willing to participate in studies – we are in TX though. Please help us get in contact with someone who can help. PLEASE!
Vicki
I have an 11 year old daughter that was prescribed miralax for constipation when she was about 4 years old, before that she was very loving, smiled happy little girl. But after she started taking miralax she became very angry, yelling, outbursts always wanting her way. I have taken her to counselors, psychiatrists and they all keep telling me that I need to learn how to disapline but I have two other children that are fine one older and one younger. Recently her mood swings have been off the wall even had to call the cops on her because she was attacking me in Walmart. I really need to get her the proper help now that I see this I will be bringing it up to her doctors this week. Also I have had to stop working because she can’t be left with anyone or else she will hurt them or start a tantrum. She runs my life and I am exhausted!
Dawn
My son was on miralax from age 15 to 17. His pediatrician kept refilling his prescription every visit giving him plenty of refills each time we mention his constipation. I asked if it was safe to keep taking it so long and was told it was fine, it’s just fiber. My son was diagnosed March of 2016 with colitis and by November he had severe ulcerative colitis. His immune system keeps atacking his colon and he has been admitted to the hospital 4 times since Sept. At 19 yrs and 6’1 he dropped down to 105 pounds suffered severe vomiting, diarrhea with blood, severe blood loss, protein in urine, high platelet counts, vitamin deficiencies and severe anemia as well as emotional problems. Has told me numerous times that this is no life and he wishes we didn’t care about him so much so he could just give up. Had to take him for emergency blood transfusion and iron infusion last week.
Mike
Our son was diagnosed with epilepsy after 5 years of miralax use; he also had a multitude of neuropsychiatric side effects. We weren’t getting anywhere with the hospital so we found a naturopath; healed his gut and many of his symptoms improved or went away. Come see us in our FB group Parents Against Miralax.
Erin
My daughter has been prescribed miralax since she was 2ys old. She is a very angry child and has had problems with rage ever since she was a toddler.
Helen
My son was given rx for mirilax ages 3-4-5 for constipation. That is when he became very different. He started removing himself from any social activities. He got very mean and hated everyone and everything. Time went on and he got off the mirilax because they discovered that he had acid reflux. He started low dose of zantac and that took away the constipation all together. He never did get over the psychiatric problems. Over the years he has developed strange behavior, like the need to be home at 3pm. He has kept me and his brother up all night long at times arguing over silly things. He was dx with bipolar/ manic depressive disorder !. Even at the psychiatrist office he went wild over nothing police had to be called to restrain him so I could speak with the doctor. He is 16 now. He will not take meds because of the fear of them. Especially respridol. I am horrified to find this out. That is definitely when he changed. I even got the med cleared through his urologist because he was born with kidney blockage in the upj. They assured me it was completely safe.
Sandra
My 12 yr. old grandson has been taking Miralax for a number of years due to having Hyrsphrung’s Disease. It has been ordered a does of two capfuls three times a day. He was a well behaved kid until we started seeing a Pediatric GI doc who changed him from once daily to a more frequent does of three times daily. Now it’s a struggle everyday waiting to get a call from the school or his brother saying he is having temper tantrums. We have also seen Psychologists, Therapists, School Counselors without any answers. We are down to medicating him now when he will agree to take the medicine which is not very often. No one sees this side of him that I see because I am the one that is with him the most. I was considering home schooling him just to keep him out of trouble. This really answers a lot of my questions about why he is like he is with his behavior. I have blamed everyone including myself for his outbursts and temper tantrums. I know it’s not the real person he has been raised to be.
Angela
Please HELP!!! My 9 yr old daughter has been given Miralax since age 2 we have to deal with such erratic violent aggressive behavior to the point of our other children being hurt, adults that come into contact with her being hurt, homicidal threatening, obscenities yelled at us constantly, and complete chaos and turmoil in our home daily. I had to quit my job to be home in order to be available whenever the school needs me or for therapy appointments. She has been placed in 2 different residential tretention centers, sent to a diagnostic research facility, and has been in several acute care facilities. She has been on several medications for behavior and nothing is working. She also has development delays and has the mentality of a 2 to 4 yr old.
Lisa
I am horrified at reading this. My Son….who turned 6 2 weeks ago is about to start seeing his THIRD therapist. Before that it was a behavioral specialist. He was put on Miralax by his pediatrician at age 3. I questioned the label saying that it should not be taken for more than 7 days, but the doctor said to ignore that and keep giving it to him. He took this for probably at least a year in which time his behavior went from a strong-willed 3 yr old to a now insane, misbehaved tormented child. His manic episodes have gotten so bad that he will flip on a dime over something as little as losing his Lego privileges for the night for refusing to do his homework. By flip on a dime, I mean the tantrum escalates to him screaming obscenities at us like “stupid fu**er, little b**tch, I’ll kill you with a knife”, and even worse. We remove him from the situation in which his younger Brothers are watching and put him in his room only to have him destroy toys etc. Hes screamed “you want to kill me don’t you? I will just kill myself.” Im not talking just yelling. I’m talking about full fledged demonic like behavior. Him hitting myself or his Dad.Therapist were not getting the full picture, so we started filming it. We have manic episodes like that at least once maybe twice a week, and at least one “meltdown” a day. Life is SO hard and exhausting with him. He’s such a smart loving boy sometimes, but other times, its near impossible to deal with. And I have eight children…..yes EIGHT. 4 girls and 4 boys. They are ages 20 – 15 months. The boys are DEFINATELY more difficult than the girls, but none of my children are ANYTHING like my one Son. His Father and I have spent HOURS trying to figure out what could possibly be wrong. Finding all this out about Miralax has me spun.
Jessica
My son is 9. He has been perscribed Miralax or Polyethylene Glycol 3350 powder for about 18mo now. In that timeframe we have also seen a dramatic change in his behavoir. He is aggressive, angry, screams and then is extremely sad. His behavoir is extremely erratic and very intense. We thought it may be a phase but the more we read into a lot of these concerns, the more we seem to be connecting dots. We would also like future contact regarding this study. Thank you
Terri
My son is 5 yes old and has been taking miralax since about 3 1/2 to4 yrs old. He was a very happy playful easy to get along with kid. After taking miralax he is aggressive toward people, threatening to kill people. He is very unhappy. He acts out at school for no reason. He is now in therapy and is taking meds (I dont think he needed before miralax). I would like to be part of this if allowed.

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