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One of the most widely used over the counter medicines for constipation has never been approved for use by children. Nonetheless, doctors often suggest it and parents often administer it to constipated kids, sometimes for years.
Now the FDA has asked researchers in Philadelphia to give polyethylene glycol 3350 (aka MiraLAX) a second look.
Doctors have assumed that PEG 3350 is not absorbed into the body, but no one has checked to make sure that young children handle it in the same way as adults. The FDA revealed recently that several batches of the drug tested in 2008 contained small amounts of ethylene glycol and diethylene glycol, toxic compounds found in antifreeze.
A health advocacy group, the Empire State Consumer Project, petitioned the agency in 2012 to study the safety of this laxative. The new research will investigate whether the compound has psychiatric or behavioral side effects such as tics or obsessive compulsive disorder, a possibility that is of grave concern to parents.
Catherine Saint Louis of the New York Times has been reporting about MiraLAX concerns for years. In 2012 she wrote:
“Despite the drug’s popularity, it has never been approved by the F.D.A. for pediatric use. In 1999, when the F.D.A. first approved Miralax, the patient materials included the warning: “Miralax should not be used by children.” In 2009, an F.D.A. drug safety oversight board raised a number of concerns about PEG’s use in children, including the uncertainty of the long-term effects of large doses, but concluded that current evidence does not suggest that PEG causes severe side effects.
“Even so, some doctors said they are concerned about the lack of information about its long-term effects. ‘We don’t know 30 years from now what will happen,’ said, Dr. Carlo Di Lorenzo, the chief of the gastroenterology department at Nationwide Children’s Hospital in Columbus, Ohio.”
On January 5, 2015 her headline read: “Scrutiny for Laxatives as a Childhood Remedy.” She went on to write:
“Doctors have long recommended these laxatives for their convenience and on the grounds that very little PEG 3350 is absorbed in the intestines. But the F.D.A. says there is little data on its absorption in children, especially the very young and chronically constipated. The agency never approved long-term daily use of the laxatives, even in adults.
“Moreover, for years the F.D.A. has received occasional reports of tremors, tics and obsessive-compulsive behavior in children given laxatives containing PEG 3350. It is not known whether the laxatives are the cause.”
We know that many visitors to this website love MiraLAX. It works. But do take a minute or two to read the latest New York Times report. It poses some challenging questions. We also encourage you to share your experience below.
rob
middletown
I am 81 and have been on Miralax for at least seven years. I really can’t get along without it. My endocrinologist, primary care, and cardioligists all say it is perfectly safe.
Martha
Ohio
My daughter, now 16, was on Miralax daily for several years from around age 3 or 4 and then on and off for a few years after that. She did develop some strange tics during that time. They eventually went away. She also complained of blurry vision. I can’t really say how this correlates with her Miralax use because we were told by the Dr. that Miralax was totally safe so I wasn’t looking at it as a potential problem. It wasn’t until I read the NYTimes article in 2015 that I realized there could be a relation. She still has some ongoing health concerns that others are reporting. I have no idea if they will ever be attributable to her Miralax use but I am dismayed that her physicians all continue to recommend Miralax to her and when I bring up my questions about the safety of Miralax, not a single one of the Drs, pediatric or adult, was aware of any issue and this is in a large academic hospital and research community.
N
here
I am an optometrist who had a woman bring her 9yo daughter in, with complaints of blurry vision and eye pain. Her eye health was unremarkable and she did not need glasses. She said the daughter was on Miralax for about two days when the symptoms began, and I saw her 1-2 months after that. She discontinued the Miralax after the 2 days use. Does anyone else have visual symptoms with Miralax?
Jessica
WV
My daughter is 7 and has been treated with miralax on and off for the last three years. She developed “blurry vision” and couldn’t see the eye chart so I got her in to see the eye doctor that day and she had 20/20 vision. I’ve had her to two different neurologist in the last two years to test for seziures (EEG’s negative). The doctor said it was probably just a “tic” and would go away. She had 3 miralax cleane outs about two month ago and has been on 2 capfuls everyday. Her “Tics” seemed to go away while off miralax. I find this very alarming and wonder now if miralax is what has caused her all of these issues!
Katie
FL
My Daughter was on and off Miralax from age 6-10, she has complained of blurry vision and her eyes hurting?!?! never could figure out why? We have had her eyes checked several times and the her sight is perfect every time. She is now 11 and taking Magnesium when needed.
Carrie
Brentwood, Ca
My daughter is 4 yrs old. She has been on Miralax for the last 10 months. It is what her pediatrician & GI dr told us to do for her constipation. I trusted them. After a few months, she started biting her finger nails, chewing on her clothes, developed selective mutism & was not able to control her bowels & wouldn’t always know if she had soiled herself until I had checked. I mentioned the anxiety problems to her pediatrician & she has now recommended taking her to a behavioral psychiatrist. I currently switched pediatricians & dropped the GI dr on moms intuition & started my own research on it. I will never give my daughter Miralax again!! Any ideas on natural clean out methods, I would appreciate. I started her on pear juice & she eats lots of fruits & veggies already.
Penny
Vermont
My granddaughter at age 2 was pretty much toilet trained, then came the day someone in family let her eat too much string cheese and she was so bound up that she suffered pain and bleeding when she finally was able to poop. After that she’d try to not go by crossing her legs. She is now almost 5 and has been back in diapers as Dr.’s all prescribed miralax and she can’t even tell when she’s soiled. Got referral form her doctor to Medical Center of VT and only saw Physician’s Assistant who continued her daily use of it. X-rays show such bad blockage still, that it’s pressing against all her organs. And yes, her behavior has changed dramatically. Why can’t western medicine do better than this? Who can you trust?
Bria
Carmel, IN
I have been doing a lot of research on this as my 6 year old daughter has been on Miralax since she was 1years old. I have found recipes for constipation candies that you can make at home. You can just google constipation candies and they will come up. I have added chocolate to ours and removed the lemon juice and have her drink lemon water. My daughter will not drink juices so this was our best bet. I can’t tell yet if it is totally working but it’s trial and error with her and what will work for her body. Hope that helps.
mike k
If you’re looking for an alternative to miralax or any other laxative consider joining the FB page “parents against miralax” and the yahoo group “miralax”.
mike k
Madison, WI
Anything but a laxative…..try Magnesium. Once the impaction is cleared, increasing fiber and water while decreasing dairy works well. Laxatives are not meant to be used long term, Magnesium is a mineral where many people are deficient in magnesium a supplement may do you some good.
“Repeated use of laxatives in higher and higher doses makes the colon less able to respond naturally to the need to have a bowel movement.” found here; http://www.cancer.gov/about-cancer/treatment/side-effects/constipation/GI-complications-pdq#section/_15
Shannon
Toronto
My daughter takes a all natural product called Ageless Hydro-C
Ordered on line and it works great for chronic constipation.
Viktoria
Parma ohio
My son couldn’t sleep he was always telling me, “I am scared,” swelling so bad at night…we stopped mira lax 3 days ago and he sleeping very well…my son is 5 years old..
Mike
Madison, WI
It’s very well documented that PEG3350 lowers my sons seizure threshold, now trying to prove that PEG3350 caused his seizure disorder remains a challenge. Just 12 months ago he was a very normal, happy, healthy young man. He was on the talented and gifted math team as a 2nd grader now he struggles to do basic math.
He has serious anxiety, ocd behaviors along with being bi-polar. While on trileptal (contains PEG3350) he had more seizures during that 30 day period then any other 30 day period to date; clean out using miralax in September of 2014 he had many seizures which often included vomiting and then in January 2015 GI did a clean out using an NG tube and golytely, he had 21 seizures in 9 days. Our longest seizure free stretch is 8 weeks (happened twice).
There are other options to relieve constipation; better diet, increased water intake and less dairy, a magnesium supplement, more fruits and vegetables and less processed foods.
Lorena
Co.
I have a 12 year old son who has been on Miralax since he was about 3. He has cronic constipation due to low muscle tone and C.P. Without he plugs up, but I want him off it. Looking for anything that would help. Starting to see behavioral problems .He also deals with global delays.
Tracey
My daughter was on massive amounts (double the adult dose) daily from 4 to 6years of age for chronic constipation. She developed Aspergers like and OCD behaviors she did not have prior to the miralax. When my previously calm easy going daughter began compulsively licking my arm when she was nervous I went looking for answers… A quick google search revealed other parents with the same worries. We have stopped the miralax and switched to lactulose because no natural remedies work for us (don’t give me any suggestions we have tried every one times ten) . Lactulose requires a prescription but it tastes sweet and we haven’t observed any side effects in almost 3 years of use. Her behavior has altered since quitting the miralax but she is still a different girl…. Such a concrete thinker, doesn’t get social cues, she wasn’t that way before miralax. I won’t let anyone tell me it is safe for her, if we have to call it an allergy then fine. We left her gastroenterologist over it. He asked us to try it miralax again after being off it for awhile and we did ( he said it was all in our heads) and she immediately began licking and having anxiety attacks. She will never take it again.
Meg
oshkosh, wi
my son has been on miralax since it came out. He is now 23 years old and still using it. He also has autism, non-verbal, anxiety, OCD, along with physical disabilities. I thought it was a miracle drug. Before that we tried everything withou success. He would roll around on the floor in pain and he has an extremely high pain tolerance. We had to give him enemas often and had a prolapsed rectum twice.
He has severe self injurious behaviors. I am worried that miralax is contributing to this. Is senacot safe? Any other suggestions for alternatives?
Miki F.
Washington
Give a kids a pile of chocolate candy and they will not need a laxative.
andrea
laxative’s meant for adults , and it is being given to children?!
Linda S.
rochester, NY
I used to recommend alternatives to Miralax, which originally was pretty pricey. I’ve found that frequently, a small can of fruit nectar (not juice) works as well. They come in many flavors that kids like; pear, peach, apricot and peach. Works pretty well , without cramping or discomfort.