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Katy TX News – New FDA Study on Miralax and Children

Katy, TX News (February 3, 2015) – Dr. Eric Chiou, pediatric gastroentrologist at Texas Children’s Hospital, examines the safety of a commonly-used ingredient in medication recommended for constipated children:

“Recently, there have been several media reports on a new study sponsored by the U.S. Food and Drug Administration (FDA) looking at the main ingredient found in Miralax, an over-the-counter medication for constipation commonly recommended by pediatricians and pediatric gastroenterologists for use in children.

The new FDA-sponsored study aims to look at how polyethylene glycol 3350, or PEG 3350, affects children long-term. On the one hand, just because the FDA is doing a study does not mean that PEG 3350 is dangerous. On the other hand, I always encourage families to obtain information from reliable sources about the medications and treatments used for their children in general. Many of our patients and families have questions and concerns about PEG 3350 which I will try to address below.

What is PEG 3350?

Polyethylene glycol (PEG) is a water-soluble, inactive ingredient of which only a very small amount is absorbed in the gut or gastrointestinal tract, the rest moves through the body. PEG is non-toxic and has no effect on the body. Commonly used brand names of PEG 3350 available in the U.S. are MiraLax and GlycoLax.

How does PEG 3350 work in the treatment of constipation?

PEG 3350 helps constipation by holding more water in the bowel, making stool softer and easier to pass. The effect of PEG 3350 is not immediate, and may take 24 hours or more to work.

Is PEG 3350 currently approved for use in children?

No. PEG 3350 is currently approved by the FDA for use in adults, but is not approved for use in children. A drug that does not have FDA approval for use in children does not mean the drug is unsafe. It usually means the drug has not been tested by the manufacturer in very large trials of children specifically for FDA approval. This may happen for several reasons such as lack of funding and ethical issues in performing some type of studies in children. Many commonly used medications are not specifically FDA approved for use in children less than 16 years.

Is PEG 3350 effective for treating childhood constipation?

Yes. Several scientific studies have shown PEG 3350 to be more effective in treating constipation in children when compared against placebo (sugar pill) as well as other laxatives such as lactulose and milk of magnesia. The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, endorses the long-term use of Miralax in its guidelines for the treatment of children with chronic constipation. 

Is PEG 3350 safe for use in children long-term?

Several research studies have shown PEG 3350 to be safe in children when used for several weeks to several months. Currently there have been no studies specifically on the use and safety of PEG 3350 in children for longer periods of time. It is common for pediatric gastroenterologists to prescribe PEG 3350 for chronic use and there have been no reports of serious, long-term side effects in the medical literature.

Why is the FDA sponsoring a new study on the safety of PEG 3350 and what new information do they hope to find out?

The FDA is interested in investigating the safety of PEG 3350 use in children and for prolonged periods. Although PEG 3350 is not absorbed by the gut due to its size, there are concerns that smaller compounds, such as ethylene glycol, could be found as impurities in the manufacturing process of PEG 3350 or formed when PEG 3350 is broken down within the body. The FDA is investigating if these smaller compounds are absorbed by the gut and accumulated in the bodies of children taking PEG 3350. Some families have reported concerns to the FDA that some neurologic or behavioral symptoms in children may be related to taking PEG 3350. It is unclear whether these side-effects are due to PEG 3350. This study is the first step towards trying to determine if there is truly a link.

Are there other effective alternative treatments/medications for constipation in children?

Multiple options are available for treatment of constipation in children. Stool softeners, stimulant laxatives, dietary changes and behavior modification are used alone or in combination, but evidence regarding the effectiveness of specific treatments is limited. Other medications for control of constipation include lactulose (a synthetic, non-digestible sugar), milk of magnesia/magnesium hydroxide, mineral oil or stimulant laxatives (senna, bisacodyl). Questions about potential risks of each medication should be discussed with your child’s health care provider.

What should I do if my child is currently taking PEG 3350?

Generally speaking, if your child has been prescribed PEG 3350 as part of his/her treatment plan, and you feel this medicine provides benefit, you should feel safe continuing PEG 3350. At this time, PEG 3350 appears to be safe based on current medical literature. We recommend discussing any concerns you have about the safety of PEG 3350 with your child’s health care provider. If you would prefer for your child to stop taking PEG 3350, discuss other treatments options with your child’s health care team before stopping PEG 3350 therapy. Although abruptly stopping PEG 3350 is not considered dangerous, it could lead to a relapse/worsening of constipation.”

Katy Magazine would like to thank Dr. Chiou and Texas Children’s Hospital for sharing their expertise on this important topic with the community. 

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