Tag Archives: is miralax safe

Will Lubiprostone Help Children with Functional Constipation?

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A recent open-label study of lubiprostone examined its use in children younger than 18 years (2007-2008) at 22 U.S. centers (JPGN 2014; 58: 283-91).

Lubiprostone (Amitiza) activates chloride-channel protein-2 in the gastrointestinal epithelium and promotes secretion of chloride ions and fluid.  This results in more frequent bowel movements (BMs) and improved motility.  To determine its safety and effectiveness in the pediatric population, the investigators enrolled 127 patients (124 were treated and analyzed and 109 completed the 4-week study).  After a 2-week observation period, several doses of lubiprostone were compared: 12 μg QD, 12 μg BID, 24 μg BID.  There was no placebo group.  The mean age of the participants was 10.2 years.

Results:

  • Mean spontaneous BM frequency increased from baseline: 3.1/week versus 1.5/week.  Overall, at each week in treatment ≥ 43% achieved ≥ 3 spontaneous BMs/week.
  • 62% experienced a spontaneous BM within 48 hours of starting treatment.
  • Common adverse reactions: Nausea (18.5%), vomiting (12.1%), diarrhea (8.1%), abdominal pain (7.3%) and headache (5.6%). Overall, 65% of patients experienced ≥ 1 adverse effect and this was highest (78%) in the subset of patients receiving the highest dosage

Bottomline: Current guidelines recommend osmotic agents like polyethylene glycol (PEG) (Miralax) as first-line treatment.  This short-term study shows lubiprostone may be an alternative in nonresponders, though more data on long-term outcomes are needed.

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Miralax Safety

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Periodically questions about the safety of Miralax arise. Recently, several colleagues have received some questions about the use of Miralax due to information on the internet. You may want to familiarize yourself with this link due to the misinformation which is provided:

http://www.gutsense.org/gutsense/the-role-of-miralax-laxative-in-autism-dementia-alzheimer.html

Some of the misleading statements:

  • Miralax has never been tested for safety in children
  • Miralax makes one cancer-prone by leaving the colon unprotected
  • Miralax may result in severe malnutrition ..leading to Autism
  • Miralax can cause memory loss and neurologic side effects

It is true that there is not enough adequate long-term data on the use of Miralax, though there are studies showing its effectiveness/safety (see below).  However, according to the FDA, there are no neuropsychiatric warnings needed for Miralax:

As with all medications, one has to weigh the risks and the benefits.  Clearly, the risk and consequences of untreated defecation problems can be severe in some children and may have terrible adverse effects on daily living.  The known safety profile of Miralax is very good and its usage has been recommended by the American Gastroenterological Association (AGA) and by the North American Society for Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) in position statements on the treatment of constipation:

An article from NY Times on this subject:

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Related references:

-Aliment Pharmacol Ther 2011; 33: 33-40.  Comparison of golytely vs miralax.
-Gastro & Hep 2008; 4: 489.  Safety/effectiveness of PEG3350 as sole agent for cleanout in 245 adults.  Used 204 gram in 32 oz of water.
-Pediatrics 2006; 118: 528.  Data on safety and effectiveness in 79 children (39 c PEG, 40 c MOM).  PEG outperformed MOM.  compliance for PEG was 95%, after 12 months, 62% improved c PEG and 33% recovered (did not need med anymore).
-JPGN 2004; 39: 536. n=75.  good experience with infants & toddlers; 85% short-term/91% long-term success.
-JPGN 2004; 39: 106.  Miralax cleanout: 4 glasses of Miralax, clears , two doses of senna or bisacodyl, & 1 saline enema.
-J Pediatr 2004; 144: 358.  4 day cleanout with Miralax, 1.5g/kg/day; last day with clears.  No enemas given.
-Arch Pediatr Adolesc Med 2003 Pashankar DS et al; n=83. Rx avg 8.7mo. insignificant adverse effects. no loss of efficacy
-Clin Pediatr 2002; Gremse DA. Lactulose & Miralax equivalent , but Miralax preferred
-JPGN 2004; 39: 197.  Published use in infants, n=28
-JPGN 2003; 37: 329 (9A) use of Miralax to 2mo or older, n=23.
-J Pediatr 2002; 141: 410-14.  PEG 3350 at doses of 1-1.5g/kg/d for 3 days relieved an impaction in 95%.
-JPGN 2002; 34: 372-377. n=28 pts + 21 pts c MOM control.  61% vs  67% doing well at 12 month f/u.
-OnlineJournal of Digestive Health 1999; 1.  Miralax results in good long-term success without salt absorption.
-J Pediatr 2001; 139: 428-32.  Mean effective dose was 0.84 g/kg/day (range 0.3-1.4 g/k/d) n=24 (for 8 weeks) 18mo to 11 years.
-JPGN 2001; 32: 514. Safety of miralax & references.