Children experiencing constipation may be treated with laxatives, enemas, or stool softeners, with one such treatment being Miralax.¹ Recently, concerns have grown regarding the use of Miralax in children and whether there may be a related onset of new neuropsychiatric conditions such as anxiety, mood swings, and seizures.^2,3 The U.S. Food and Drug Administration (FDA) determined no changes to the label of Miralax were needed based on these reports.⁴ However, the relationship between Miralax and neuropsychiatric conditions is not well understood, and the interplay of behavioral and psychological conditions that lead to stool withholding and constipation complicates the picture.⁵ 

To further understand the relationship between Miralax and neuropsychiatric conditions, we studied 645,294 children who were prescribed Miralax and compared them to 105,963 children who were prescribed a different constipation medication. Other constipation medications were used as a control to adjust for the established relationship between constipation and neuropsychiatric conditions.⁶  

We found that children aged 6 to 11 treated with Miralax were less likely to experience new or recurring symptoms of depression compared to those treated with a different constipation medication, as seen in Figure 1. Additionally, recurring symptoms of seizures and mood swings were also less likely among children aged 6 to 11 treated with Miralax. We did not find a statistically significant change in the likelihood of new seizures, new mood swings, new anxiety, or recurring anxiety. 

Among children aged 12 to 17, we found that those treated with Miralax were less likely to have new symptoms of depression compared to those treated with other constipation medications, as seen in Figure 2. However, they were more likely to experience new and recurring seizures, new mood swings, and new and recurring anxiety. We did not find a statistically significant change in the likelihood of recurring depression or mood swings. 

These data come from Cosmos, a dataset created in collaboration with a community of Epic health systems representing more than 294 million patient records from 1,600 hospitals and more than 37,000 clinics from all 50 states, Lebanon, and Saudi Arabia. This study was completed by two teams that worked independently, each composed of a clinician and research scientists. The two teams came to similar conclusions. Graphics by Brian Olson. 

References

1. Paul A, Punati J. What is the evidence for over the counter laxatives to treat childhood constipation? Curr Gastroenterol Rep. 2021;23(11). doi:10.1007/s11894-021-00818-1 
2. Becker HA. Is Miralax really safe for kids? Parents. January 7, 2015. https://www.parents.com/parents-magazine/parents-perspective/is-miralax-safe-for-kids-an-expert-weighs-in/. Accessed November 20, 2024. 
3. Hussain SZ, Belkind-Gerson J, Chogle A, Bhuiyan MAN, Hicks T, Misra S. Probable neuropsychiatric toxicity of polyethylene glycol: roles of media, internet and the caregivers. GastroHep. 2019;1(3):118-123. doi:10.1002/ygh2.336 
4. October – December 2011. U.S. Food and Drug Administration. January 30, 2020. https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/october-december-2011-potential-signals-serious-risksnew-safety-information-identified-adverse-event. Accessed November 20, 2024. 
5. Rajindrajith S, Devanarayana NM, Benninga MA. Childhood constipation: Current status, challenges, and future perspectives. World J Clin Pediatr. 2022;11(5):385-404. Published 2022 Sep 9. doi:10.5409/wjcp.v11.i5.385 
6. Hosseinzadeh ST, Poorsaadati S, Radkani B, Forootan M. Psychological disorders in patients with chronic constipation. Gastroenterol Hepatol Bed Bench. 2011;4(3):159-163.