Check out the PedsDocTalk YouTube Video: MiraLAX Myths for more information and research about MiraLAX for children, including constipation signs, is MiraLAX safe, and does MiraLAX cause psychological or neurological problems.
MiraLAX is a common medication recommended for constipation. Approximately 3% of children are affected by constipation, and 1 out of every 20 pediatrician visits is related to constipation concerns. Constipation is the passage of infrequent, hard, and sometimes painful bowel movements accompanied by abdominal pain or blood in the stool. Constipation is most commonly seen during transition periods, like potty training, starting a new school, or traveling. If you have specific questions about potty training or stool withholding, check out the No-Pressure Potty Training Course for more information and tips!
Have you heard MiraLAX can cause anxiety, depression, or other behavioral changes? It’s important to address this misinformation with research to understand MiraLAX – what is it? Is it safe, and what are the possible side effects?
What is MiraLAX?
MiraLAX is a brand-name over-the-counter (OTC) laxative. The main ingredient is polyethylene glycol 3350 (PEG 3350). MiraLAX is an osmotic laxative, meaning very little medication is absorbed, and instead, the medication works to pull extra fluid into the intestine to soften stool. For children, it’s dosed based on a patient’s weight and typically works within 24 hours of taking it.
Several randomized control trials (the gold standard for research) show that PEG is more effective at controlling constipation in children than a placebo or other laxatives like lactulose or milk of magnesia. There is a range for dosing, and sometimes the dose needs to be titrated until relief is noted, but typically when used as directed, PEG 3350 is effective at relieving constipation.
Is MiraLAX safe?
Research and clinical expertise show that MiraLAX is effective; however, safety is another crucial element. Studies on PEG 3350 have shown that it is generally safe for adults and children. Several research studies have been done on children using the medication for weeks to several months, and no significant adverse effects were noted. Studies have not been done on use for longer periods. Still, it is common for pediatric gastroenterologists and pediatricians to prescribe PEG 3350 for long-term use, and there have been no reports of serious adverse effects.
One circulating concern is that MiraLAX causes psychological or neurological problems. These claims started circulating in the mid-2000s when there were 167 reports of adverse effects in children who took PEG 3350. Of these 167 claims, 37 included neurological or psychological symptoms, including rage, aggression, mood swings, depression, anxiety, slurred speech, and behavioral changes. In 2012, a petition was sent to the FDA requesting an investigation into the claims. The FDA awarded a grant to the Children’s Hospital of Philadelphia to study PEG use in children 0-17 years of age to study and possible adverse effects. This specific study is still ongoing.
One of the most cited studies when discussing the concerns related to PEG 3350 was a study completed in 2019. The study looked at self-reported adverse effects with no controls. Most of the adverse effects were reported by parents but never verified by a clinician and were reported shortly after the increased media coverage on PEG 3350 safety concerns. The adverse events reported could not be verified to be caused by PEG, and the behavioral changes were never proven or verified by a psychological exam.
In contrast, over 100 other studies demonstrate that PEG 3350 is safe and effective at the appropriate pediatric dose. The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, the FDA, and CHOP all agree that the current evidence does not support that MiraLAX causes neurological or psychological effects.
Another common concern related to PEG 3350 is whether you can build up a tolerance if you use it long-term. MiraLAX works by pulling extra fluid into the gut but does not affect the nerves or muscles of the gut, so you can’t build up a tolerance or become “resistant” to it.
Commonly known side effects of MiraLAX
It’s important to remember that PEG 3350 is not absorbed into the bloodstream. Studies show that it does not affect the body’s electrolyte balance. The most common side effects are typically limited to the GI tract, including diarrhea, nausea, stomach pain, and bloating.
It is recommended that PEG should be used with caution in children with a history of electrolyte imbalance, kidney disorder, seizure disorders, or GI obstruction or blockage.
Tips on navigating the use of MiraLAX with this information
Although some parents report adverse effects, there is a lack of data to demonstrate these claims. Clinicians continue to prescribe this medicine without any major issues. Whenever there are concerns about medication, it is important to speak with your child’s clinician for the best action plan. Remember, there are often other interventions to trial before MiraLAX.
The current evidence demonstrates that MiraLAX is considered safe and effective to be used in children as long as you’re following the directions of your child’s clinician. Dosing should never be determined at home. Talk to your child’s clinician if you are still concerned about using MiraLAX.