FDA Regulation

PEG 3350

The Food and Drug Administration (FDA) has awarded a grant to Children’s Hospital of Philadelphia to study whether there are any adverse effects to prolonged use of PEG 3350 in children with chronic constipation. With the announcement of the study, there has been a new wave of media coverage questioning the safety of Miralax and other laxatives that contain PEG 3350.  This media coverage will be accompanied by questions and concerns from parents whose children are being treated effectively for chronic constipation with PEG 3350.   

To help pediatric gastroenterologists and pediatricians answer questions, the NASPGHAN Neurogastroenterology and Motility Committee has prepared a frequently asked questions document on PEG 3350.  

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.  

Fecal Microbiota Transplantation

Drug Shortages

IND Requirements for Human Research

Biosimilars