Following our posts on the safety of Miralax and answering some frequently asked questions about Miralax use for constipation, we heard one resounding question:

"When should I be worried and when should more workup be done?"

Benign (or not concerning) causes:

• Constipation starts with a dietary change or at the time of toilet training
• Children show a stool withholding behavior
• Things resolve easily with stool softeners

But what are the warning signs? When should you be worried? Here are nine symptoms or signs that more workup should be considered for your child’s constipation:

1. Constipation has been present since birth or early infancy
2. Any other symptoms with constipation-fever, vomiting or diarrhea
3. Bleeding in the stool or from the rectum
4. Swelling or distension of the belly
5. Long, narrow stools (sometimes called “ribbon stools”)
6. Urinary accidents or recurrent urinary tract infections
7. Poor growth or weight loss
8. Other, non-belly symptoms, especially neurologic symptoms like weakness or abnormal sensation in the legs
9. Abnormal findings in the lower back (birthmarks or hair along the spine)

The workup for constipation can vary depending on the child’s symptoms and exam findings. Some things that might be considered:

Imaging -Most commonly the child will undergo a barium enema which is an X-ray that is enhanced by an enema that shows up on the X-ray. If there are concerns about the child’s neurologic symptoms, an MRI of the spine can be conducted to rule out something called a tethered cord.

Blood work - Depending on the child’s symptoms, blood testing for the following could be indicated: celiac or thyroid disease, calclium and blood lead levels.

In severe constipation or constipation that does not resolve, a referral to a gastrointestinal doctor can be helpful for further workup and treatment recommendations.

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If you missed the first story, please check it out here. Now for some constipation and Miralax AMA responses:

1.Is short term use of MiraLax for a colonoscopy OK?

Quite a few studies have looked at short-term use of MiraLax for bowel regimens for colonoscopy, which showed MiraLax to be safe and effective (and much more tolerable than more “aggressive” regimens).

2.What are the diet modifications for treating constipation?

Foods that are high in fiber should be offered to children who are experiencing constipation. Some examples would be high-fiber cereal (more than 5 grams per serving), fruits (pears, strawberries, apple with skin, dried fruits) and vegetables (beans, sweet potato, lentils). Children should also be encouraged to drink 32-64 ounces of water per day. One common cause of constipation is ingestions of more than 32 ounces of cow’s milk.

3.What are the treatment alternatives for MiraLax?

Of course, diet and fluid intake are the primary means of treatment and should be for all children. There are other medication alternatives to MiraLax. Some work like MiraLax and are osmotic (draw fluids into the bowels) but others are stimulating (they cause the intestines to contract). Each has its own side effect profile so I would recommend discussing with your pediatrician.

4.Is there tolerance or dependence on MiraLax over time?

According to the available information about MiraLax, there should be no reason to believe that a tolerance to MiraLax could develop. Kids should be transitioned to a high-fiber diet and weaned off MiraLax as soon as possible.

5.Are probiotics an option for treating constipation?

A few small studies looked at the use of certain probiotics for constipation, but nothing I can find on a large scale study or a firm suggestion of which bacterial strains and dosage should be included.

6.Is MiraLax absorbed into the bloodstream?

Based on the available information, there is no reason to believe that MiraLax is absorbed into the bloodstream. A current study in Philadelphia is intended to better address this question by assessing if small amounts of the substance or bi-products are present in the child’s blood.

7.Would you give your child MiraLax?

Given the available information, if my children had problems with constipation that couldn’t be relieved with diet modifications, I would feel comfortable giving MiraLax to them. Should further information from the Philadelphia study surface, I would definitely want to take that into consideration.

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.

The Studies

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.

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.