Is Miralax Safe For Long Term Use

April 03, 2017

iv min read

Parental concerns over MiraLAX laxative continue to spur closer review

Constipation is a relatively common trouble in pediatric practice, with reported prevalence rates betwixt 1% and 30%, as well as the chief complaint in 3% to 5% of visits to pediatric outpatient clinics. Because most constipation cases can be remedied through recommended over-the-counter laxatives, constipation is rarely a cause for severe worry amidst parents.

Still, ane commonly prescribed laxative medication, MiraLAX, has been the focus of meaning parental apprehension due to concerns that its active ingredient, polyethylene glycol 3350 (PEG 3350), may be linked to tremors, tics, obsessive-compulsive behaviors and assailment in children following its utilize.

William Gerson

William T. Gerson

"Understanding hazard in terms of pharmaceutical agents is complicated," William T. Gerson, Doctor, clinical professor of pediatrics at the University of Vermont College of Medicine, told Infectious Diseases in Children. "Rare complications might non appear until after medications are in widespread use and are expected even when not seen in clinical trials as both a part of statistics — number of patients studied in clinical trials tin never uncover truly rare events — and the fact that clinical trials typically limit the patient population studied, leaving out patients with preexisting diseases."

To vocalism their concerns, many parents of children exhibiting neuropsychiatric symptoms after using MiraLAX have joined activist groups, well-nigh notably the individual Facebook group Parents Against MiraLAX (PEG 3350), which at present boasts more than 12,000 members.

"We are a group of parents and family members who are confronting PEG 3350 and are here to discuss its cons. Nosotros talk over alternative options and ways to talk to doctors virtually our opposition to this very dangerous drug," Parents Confronting MiraLAX (PEG 3350) claim on their Facebook grouping. "Nosotros are not a replacement for the type of health care yous choose, we only speak from experience. You have to make your own choices and decisions based on your child and research."

Primarily recommended for short-term use to treat occasional constipation or irregular bowel movements, MiraLAX is not approved for long-term use in adults nor pediatric use past the FDA, yet it is commonly prescribed for children, a fact that has given ascent to much of the public outcry surrounding its possible link to adverse neuropsychiatric events.

"Although PEG 3350 is normally used as an osmotic laxative amanuensis to treat constipation in children, it is not labeled by the FDA for use beneath 17 years of age," Edward A. Bell, PharmD, BCPS, is a professor of pharmacy practice at Drake University College of Chemist's shop and Health Sciences and Blank Children'south Hospital and Clinics, told Infectious Diseases in Children. "Nonetheless, PEG 3350 has been recommended as a starting time-line laxative for children in guidelines published in 2014, as its efficacy is well supported by published studies in children."

Initial consumer skepticism of MiraLAX originated in 2012, post-obit a denizen petition by the Empire State Consumer Projection urging the FDA to investigate the long-term effects of PEG 3350 for long- and brusk-term utilise. The petition as well chosen for immediate recall of products containing the ingredient, and so a black box warning could be added too every bit review and disclosure of all clinical trial results apropos PEG 3350.

Edward A. Bell, PharmD, BCPS

Edward A. Bong

In 2014, the asking received partial acceptance and fractional denial, claiming that the agin effects demonstrated in the petition were bereft to implement a boxed warning. In addition, the FDA was not aware of any unpublished clinical trials, and the reported agin effects did not warrant additional studies on long- and short-term use.

"In response to the citizen'southward petition, the FDA carefully evaluated published studies and reports in the FDA's Adverse Outcome Reporting System, concluding that PEG 3350 products are rubber and constructive, and a modify to the product'southward labeling is not required at this fourth dimension," Bell said.

Despite denials of imminent harm to children, the FDA agreed with the petition's claim that data concerning the safety and effectiveness of PEG 3350 in children do not exist. This lack of information prompted the administration to fund studies regarding the exposure of children to PEG 3350 and its degradants: ethylene glycol and diethylene glycol.

"Constipation, along with chronic gastrointestinal complaints, take been the focus of enormous attention over the last several decades," Gerson said. "The N American Order for Pediatric Gastroenterology, Hepatology and Nutrition and international pediatric gastrointestinal organizations accept made a priority of applying serious bookish attending to common pediatric gastrointestinal weather condition. They have led the way on establishing criteria and promoting guidelines for management available to all practitioners that are reasoned and audio. However, in that location remains a paucity of randomized control trials of efficacy let alone safety, which is acknowledged by all."

To fill this knowledge gap and examine the long-term effects of MiraLAX, researchers at the Children's Infirmary of Philadelphia take been conducting FDA-grant funded written report analyzing the effects of PEG 3350 amid children who have received medications containing the ingredient for at least 1 month.

Patients included in the CHOP study have been split up into 3 categories, including those who are constipated but otherwise healthy, those with gastrointestinal concerns like Crohn's or celiac disease and those with preexisting neurological concerns, such as cognitive palsy; a control grouping of children who take not received PEG 3350-containing medication will likewise be included in the report.

"This study in enrolling children who are chronically treated with PEG 3350 for constipation, and volition entail claret sampling for additional assay of the pharmacokinetics of ethylene glycol and diethylene glycol," Bell said. "With the conclusion of the ongoing study, additional information should become available to allow farther assay of the safety of PEG 3350 utilise in children."

Although researchers at CHOP were unable to comment on an ongoing study, which would need to exist showtime submitted to the FDA for review, Gerson recommended that pediatricians not alter their electric current practice until the results of the CHOP written report are bachelor.

Gerson also noted that despite the various alternative medications available to treat pediatric constipation — including other laxatives, stool softeners, mineral oil, sucralose and lactulose — recent constipation guidelines have switched to using MiraLAX to the betoken that the medication is ordinarily known equally "vitamin M" for its ease of use, full general effectiveness and accepted safety.

"1 needs to call back that, unfortunately, children can rarely accept the sudden onset of disturbing symptoms," Gerson said. "Given the common use of MiraLAX, hazard association is likely to occur; that by no ways is meant to infer that in that location are not rare complications or that the utilise of MiraLAX is appropriate in all situations. However, in that location are no information to support a change in practice at this time and alternative treatments are not necessarily safer." —Katherine Bortz and Bob Stott