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FDA Questions Safety of Constipation Medication

January 7, 2015 Uma Pisharody, MD, FAAP

On Monday the New York Times published an article about the FDA’s plan to research the safety of a very commonly prescribed medication, polyethylene glycol 3350 or PEG 3350 (most commonly known under the brand name, MiraLAX®).  As a pediatric gastroenterologist who often recommends this medication, I wanted to share my personal thoughts after reading the article.

First of all, although the news was certainly a surprise to me, it was a pleasant one. I was pleased to know that the FDA is looking so seriously into the matter.  I think that I’m like most pediatric gastroenterologists who, already well-aware of past decades of peer-reviewed scientific literature showing both efficacy and safety of PEG 3350, are hopeful and confident that this latest FDA-funded study will help dispel ongoing debates and controversy in the community at large regarding the absorption and long term safety of this molecule. 

Personally, I feel that much of the suspicion regarding usage of PEG 3350 stems from a lack of understanding all of the complexities of chronic constipation in children, its causes and complications.

Remember that for many children, constipation is a debilitating condition that requires years of treatment. Medication is only a small piece of the multi-faceted treatment algorithm, but nevertheless, a key piece.  As physicians committed to helping children, we do our best to choose medications wisely, while trying to do no harm, knowing that every medication carries with it some adverse effects.  We use a medication only when we know that its benefits far outweigh any potential risks.

For parents of children taking PEG 3350, I urge you to talk to you children’s physicians to learn the facts regarding what is truly known about this medication. Until the results of the FDA-funded study are fully known, there is no need for undue worry, based on a newspaper story.

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