Is MiraLax Safe For My Child?
Doc Smitty takes a look at constipation relief medication
Constipation is an incredibly frustrating problem for children and their families. Having a child with stomach pain, pain with stooling and even bloody stools because of constipation is very frustrating.
Several treatment options are available but does one of the most common options for treating constipation pose a serious risk for your child?
You may have read one of the recent media articles highlighting a concern among some families that MiraLax may lead to neurologic or psychiatric side effects such as tremors, tics or obsessive-compulsive behaviors. Previous reports have shown that some samples of MiraLax had trace amounts of ethylene glycol and diethylene glycol (which are ingredients in anti-freeze and have been linked to neuro-psychiatric problems). The FDA has fielded these concerns over time and commissioned a large study which is currently ongoing looking at the safety of MiraLax in pediatric patients.
With those concerns, I thought now would be a good time to give you some of my thoughts on MiraLax.
Treatment for Constipation
Children who are constipated often only pass stool once or twice a week, have hard stools or have stools that are large and cause pain. If constipation is very severe, it can lead to stool leakage into the child’s underwear as loose stool passes by the hard, formed stool in the intestine.
Treatment for constipation is generally based on the idea of softening stool up so that it can easily pass through the intestines. I always recommend that parents start with a change in diet and fluid intake. Children who are constipated should drink extra fluids (32-64 ounces). This is the one instance where I will recommend introducing some juice (usually prune or pear). In addition, children should eat foods that are high in fiber (think fruits and vegetables).
However, these changes are sometimes not enough. So, what do you do next? After talking with your doctor, it’s likely they will recommend a medication. Which medication? Most commonly, Miralax. But, is MiraLax safe? Should you be giving it to your child?
How Miralax works
MiraLax works by attracting water into the intestines which helps to soften the harder stool which is leading to constipation. It is a synthetic material which is manufactured in a lab (the ethylene glycol and diethylene glycol are byproducts of manufacturing). I like to think of it as synthetic fiber. One of the things that is nice about MiraLax is that it’s tasteless so it can be added to a child’s drink. You can also increase or decrease the dosage based on the child’s needs.
The FDA has not approved the use of MiraLax in children, nor has it approved its use for long periods of time. However, many children can and do take MiraLax on a daily basis.
There have been at least five open label studies focused on kids (where the participants knew what they were giving their children) which showed MiraLax to be safe and effective. These studies had about 300 patients combined. Other studies blindly comparing MiraLax with other laxatives such as lactulose and Milk of Magnesia have shown it to be either more effective or as effective and with less side effects. Children in those studies included patients taking MiraLax between 2 weeks and 12 months (most in the 2-6 month range).
The most common reported side effects in studies were: diarrhea, bloating and abdominal pain. All laboratory testing including electrolytes, liver and renal function remained normal. Of note, I could not find a single patient that was reported to have dropped out of a study based on neuro-psychiatric symptoms.
One of the most renowned pieces of evidence in medicine is a Cochrane review. The team at Cochrane reviews all the available studies and makes a recommendation about the safety and effectiveness about treatment recommendations. The Cochrane review of 18 trials (including 1643 patients) showed good effectiveness, safety. There was one child who had an allergy to polyethylene glycol but there were no other serious side effects documented.
1.As with any condition and any treatment. Make an effort to avoid medication if possible. Dietary changes and fluid intake should be the first line of treatment for constipation in all children.
2.All available studies suggest that MiraLax is safe and effective for children. I always welcome further study and will follow the results of the Philadelphia study closely.
3.Even when studies show a lack of evidence in large populations, we must always listen to our patients carefully and if a serious side effect is suggested, I would recommend stopping the medication and looking for alternatives.
4.For children who have been on MiraLax and are doing well, I do not suggest a change in treatment course. We should always reassess the need for MiraLax frequently and discuss whether a diet modification might be enough.
About the author
Justin Smith is a pediatrician and the Medical Advisor for Digital Health for Cook Children's in Fort Worth, Texas. He has an active community on both Facebook and Twitter as @TheDocSmitty and writes weekly for Cook Children's checkupnewsroom.com. His interest in communications started when he realized that his parents were relying more on the internet for medical information. He believes that strategic use of social media and technology by pediatricians to connect with families can deepen their relationship and provide a new level of convenience for both of their busy lifestyles. Dr. Smith’s innovative pediatric clinic, a pediatric clinic “designed by you,” is set to open in Trophy Club in 2017.