A recent New York Times article about the safety of Miralax and similar generic products used to treat children with constipation has struck an alarming chord with many parents.
Miralax and its generic equivalents are one of our first-line-of-defense tools for managing chronic, severe constipation. The ingredient called into question is polyethylene glycol 3350, or PEG 3350. There has been a tremendous amount of investigation into the safety of PEG 3350. In fact, it’s probably one of the most thoroughly studied molecules in our field. The available research provides a strong justification for PEG 3350 as a treatment for childhood constipation, considering both the safety and efficacy of this molecule relative to other medicines sometimes prescribed for severe constipation.
The reality is that every medication has potential side effects. In fact, the constipation therapy most commonly used for children prior to the shift to the use of Miralax had terrible side effects. Even today, the alternatives to therapies that contain PEG 3350 also have side effects, and in many cases are not as effective.
As physicians, we prescribe medications only when necessary, and when the benefits outweigh the potential side effects that may be caused by the medication. Chronic, severe constipation has been associated with kidney infection and failure, and premature discontinuation of laxative use in children with severe constipation can be harmful to normal bowel function.
Anytime we prescribe a medication, including one containing PEG 3350, we work very closely with our patients and families to adjust and modify treatment as needed in the event a patient experiences harmful side effects.
When my colleagues and I are sitting in a consult room across from a parent of a child with a painful, dangerous chronic condition, we have to make decisions with the best evidence that we have. While we are confident in our decisions to prescribe Miralax and similar therapies that contain PEG 3350 in specified limited dosages for children with chronic constipation, we applaud the FDA’s decision to further investigate the safety of PEG 3350 in children.
Ensuring patient safety is of the highest importance to our team. There is no question that obtaining more information about the drug therapies we use in our treatment of children is a worthy investment.
We hope to see increased investment by the FDA, NIH and other institutions for much more of this type of investigation into the safety of many therapies we as physicians rely on to care for our patients and families.
Dr. M. James Lopez is a pediatric gastroenterologist and Division Director of Pediatric Gastroenterology at C.S. Mott Children’s Hospital. His research interests include pediatric liver transplantation, pediatric liver disease, drug-induced liver injury, acute liver failure, transition, and medical adherence.
University of Michigan C.S. Mott Children’s Hospital is consistently ranked one of the best hospitals in the country. It was nationally ranked in all ten pediatric specialties in U.S. News Media Group’s “America’s Best Children’s Hospitals,” and among the 10 best children’s hospitals in the nation by Parents Magazine. In December 2011, the hospital opened our new 12-story, state-of-the-art facility offering cutting-edge specialty services for newborns, children and women.