The FDA recently released information that very small amounts of ethylene glycol and diethylene glycol have been found in some samples of laxatives that are comprised of PEG 3350 (the active ingredient in Miralax and other generic laxatives). Parents and pediatricians are asking whether large doses and long term use PEG 3350 laxatives in children could lead to possible side effects. At very low levels these compounds are considered safe and most likely the amounts of these compounds in PEG 3350 laxatives are so small that they do not pose a threat to children. However, no one can be certain until it is studied. To address this issue, the FDA and others are investigating whether PEG 3350 laxatives contains enough contaminants that could cause significant side effects or harm to children.
While potential concerns have been raised about use of PEG 3350 in children, one must realize that refusing to use PEG 3350 laxatives due to a possible danger can result in the occurrence of a real known danger. Multiple studies show that PEG 3350 laxatives are better than other types of laxatives for treating severe constipation. Unresolved severe constipation can have serious consequences including severe pain and life threating intestinal blockages. Years of undertreated chronic constipation can cause the loss of intestinal function to the point that part of the colon may need to be surgically removed.
Because of the real dangers from not adequately controlling constipation in children, I continue to use PEG 3350 laxatives in many of my patients. However, there are steps that can be followed to minimize the potential risk of chronic use of PEG 3350 laxatives in children:
Work with your child’s pediatrician to determine whether your child needs a stool softener.
Changes in diet can also help treat constipation. If dietary changes do not work or not an option, then consider your options. There are other stool softeners. However, one must realize that all medications have potential risks. One should work with their physician to identify whether there are reasonable alternatives to PEG 3350 for treating constipation in their child.
Start with another type of laxative in kids younger than 3 years of age.
The potential concerns with PEG 3350 laxatives are greatest for the very young. Due to their size and rapid development, children under the age of 3 would be the most susceptible to small amounts of ethylene glycol and diethylene glycol. In this age group, it would be reasonable to use another laxative, such as lactulose. Lactulose can successfully treat mild to moderate constipation, especially in the very young. Of course, some children in this age group will have severe constipation and may require PEG 3350 laxatives.
Use the smallest dose necessary to treat constipation and reduce potential risks.
I typically tell parents to use teaspoons (~5grams) to measure the doses of PEG 3350 laxatives and to adjust the dose to the lowest number of teaspoons that is needed to soften the stools. Use of teaspoons also makes it easier to know whether the child can be weaned off of the laxative. After a few months on a stable dose, I will have the parents reduce the dose by ½ or 1 teaspoon. If the child does well with the reduction for 1-2 weeks, we then reduce the dose further until able to completely wean off of the medication.
Work with a physician to determine the best time to wean off of the laxative.
Most children with constipation will improve over time and not need to remain on a stool softener. However, if the laxative is stopped too soon, then the child will relapse. Multiple relapses can result in the child having to use larger doses of laxatives and have to remain on laxatives for a longer time than if the child stayed on a smaller dose for just a little bit longer with the first use of the laxative. Many factors go into deciding when the best time to wean off the laxative is. This decision is best made by working with a physician who routinely treats children with constipation, such as a primary care physician and/or a gastrointestinal specialist.
The bottom line is that some children will struggle with constipation for years, if not for the rest of their lives. For these kids, I would say that the potential benefits from using PEG 3350 laxatives daily for years far outweighs the potential risks. More research needs to be done and as those findings come to light, and we will keep you updated.
Kent Williams, MD, is an attending pediatric gastroenterologist at Nationwide Children’s and an assistant professor of clinical pediatrics at The Ohio State University College of Medicine. Dr. Williams’ clinical interests involve all aspects of pediatric gastroenterology, with a special interest in GI disorders in children with autism spectrum disorders.
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