News of research being done to look at the safety of Mirilax was all over the media this month.
Like so many things we use and do in therapy (including therapeutic techniques), research and efficacy often come after the technique or product is being used. There is a New Research Study beginning which will investigate the long term effects of using Miralax and related laxatives containing the active ingredient polyethylene glycol.
We have parents asking about the safety based on these new articles. At this point, we are still using Mirilax and other types of stool softeners with our feeding patients who are constipated or who need assistance to stool more.We look forward to seeing the results!
Web Information:
Information on Mirilax from Bayer, the company that makes Mirilax.
The website provides this information on how it works (along with a short video and comparison to other stool softeners).
“MiraLAX® contains Polyethylene Glycol 3350, which is a completely different way to treat occasional constipation. It activates water to work in 3 ways – hydrating, easing and softening – to unblock your system naturally. “
News articles about the new research:
Autism speaks:
NY Times Article:
http://www.nytimes.com/2015/01/06/science/scrutiny-for-a-childhood-remedy.html?_r=1
Common health and reform:
http://commonhealth.wbur.org/2015/01/miralax-dilemma-parents-safe
I have always wondered why so few doctors and dietitians rarely recommend specific foods or nutrients that are known to soften the stools. For example, supplemental magnesium can be used very effectively to promote softer stools and reduce or eliminate constipation. When the body is not getting enough magnesium, constipation can result. A large percentage of adults and children are deficient in magnesium. A powdered magnesium supplement can be added to the diet to reduce constipation. The body has a “fail safe” system so that if too much magnesium is taken in, very soft stools or diarrhea will result. You can’t overdose! The appropriate amount can be figured from observing the consistency of the stools and adjusting the amount of magnesium added to the diet. As with all specific supplements, this should be discussed and monitored by the child’s physician and/or dietitian. The concern about Mirilax may provide an opportunity to encourage parents and professionals to try other alternatives that can actually improve the child’s nutritional status along with the reduction in constipation.
Thank you for your comment, I very much agree. We also find that for some children we can get softer stools with changes to formula, changes to diet, increasing fluid volume, and adding fiber. For example, We have had positive results with some children by switching them from apple based juices and foods to pear based or from moving off of soy formula to hydrolyzed dairy. However, this is a case by case basis and does need to be discussed with the child’s physician. For many of our clients, appetite and tolerance of volume is directly linked to GI motility and stooling so this issue will be an ongoing discussion in our field. Again, thank you for your comment!
I cannot comment on Magnesium, as no randomized controlled trials have been performed but trial with fiber have generally found it to be ineffective to relieve constipation in children. Given this inefficacy and the resistance of young children to eat high fiber foods, medications are more commonly used. See also the following NASPGHAN consensus document. http://www.naspghan.org/files/documents/pdfs/cme/jpgn/Evaluation_and_Treatment_of_Functional.24.pdf
We need more trials in children, and the main reason these are not performed is that funding is lacking.
Thanks for the comments Miranda, great points!
I strongly support food and nutrition alternatives for constipation as the first step. However, many doctors prefer a pharmaceutical choice for the reason cited by Miranda van Tilburg’s comment. “I cannot comment on Magnesium, as no randomized controlled trials have been performed . . .” Randomized controlled trials are designed for pharmaceutical drugs. This is needed because of the inherent risks that are involved. In order to define the safe dosage of a new drug, tests must show the level of the potential drug that kills 50% of the animals in initial trials. There are not the same mortality risks where food is involved and randomized controlled trials are not needed or appropriate for foods etc. In most instances the research is prohibitively expensive. Pharmaceutical companies do the research because they can patent the product and make large profits when a product is marketed. However, you can’t patent a food-based component such as magnesium. We just won’t see that type of research available and shouldn’t base our decision to explore its use because there are no double blind randomized studies. . . especially studies that have been replicated.
NASPGHAN issued the following statement on the use of Miralax:
“At this time, there is no evidence to support serious side effects of Miralax and similar products (PEG 3350). Most commonly reported side effects include diarrhea, bloating and nausea. No psychiatric/neurological issues are reported in the scientific literature. Similar to many commonly used medications, the use of Miralax (PEG 3350) is approved by FDA for adults only, due to lack of clinical trials in children. Its metabolism and long-term use in children are being studied. The results from those studies are not likely to be available in the near future. Like all medications, the decision to use Miralax (PEG 3350) should be based on weighing benefits and possible unproven risks. If a parent has concern about the use of Miralax/PEG 3350 for their child’s constipation, they should address it directly with their health care provider”
A FAQ is also available.
See also this interview with Dr Sood: http://radiomd.com/show/healthy-children/item/25626-is-your-child-troubled-with-constipation