(WRIC) — Tics, rage and seizures are just some of the serious side effects parents told 8News their kids were experiencing after taking the laxative Miralax. 8News first reported on the concerns last year when a study into the issues was promised.
8News has been keeping an eye on the study, wanting to share the results of it with people but on Friday 8News learned the taxpayer-funded study hasn’t even started yet
“You know quite frankly I am feeling a little betrayed,” said Mike Koehler.
Koehler, who talked to 8News from Wisconsin over Skype, is disturbed and disappointed to learn a study into Miralax has yet to begin. He’s one of the thousands of parents online who have been sounding the alarm about the laxative and its active ingredient polyethylene glycol or PEG 3350, which contains some of the same compounds found in antifreeze.”What is the effect of the chronic or long term use,” Koehler wondered.
While Miralax has lined pharmacy shelves for decades, if you read the label you’ll see it’s not recommended for children under 17. Yet 8News has uncovered doctors commonly prescribe the laxative to infants and young children.
Some families now believe it’s triggering neuro-psychiatric issues in their children. Norma Eggleston told 8News her granddaughter Carmen experienced nervous tics and aggression when she was prescribed Miralax daily for her chronic constipation.
“She would have these uncontrollable tics,” said Norma Eggleston. “If you would get too close to her, she would hit you, she would bite you, she would pinch.”
Koehler says his son Bradley was never the same after he was prescribed a large dose of it in the hospital for his tummy troubles.”He proceeded to have 21 seizures over the next 9 days,” Koehler explained.
Bayer, the makers of Miralax told 8News:
Bayer Consumer Health has a long history as a leader in the manufacture and marketing of a broad range of over-the-counter (OTC) healthcare products and nutritional supplements. The health of our consumers is our top priority.
The MiraLAX® brand became part of Bayer’s OTC portfolio in the United States in October 2014 with the acquisition of Merck Consumer Care. Miralax is an osmotic laxative that relieves occasional constipation. MiraLAX was introduced as a prescription laxative in February 1999 and was approved by the FDA as an OTC medication in 2006. OTC labeled dosing applies to adults and children 17 years and older for up to 7 days, unless otherwise directed by a doctor.
While MiraLAX is not labeled for use in the pediatric population, there have been many clinical studies conducted with PEG 3350 in pediatric populations which have demonstrated safety for short and long term use in children with a history of chronic constipation.
As part of Bayer’s ongoing commitment to consumer well-being, we regularly track, analyze and report all adverse event data related to the use of the product. Results of this ongoing monitoring support the continued safe use of MiraLAX.
With regard to the clinical study in question, it is a government-funded study by the National Institute of Health being conducted by the Children’s Hospital of Philadelphia. As Bayer is not involved in the study, any inquiries should be directed to them.”
Still, the concerns from parents prompted the food and drug administration to fund a study at CHOP, the Children’s Hospital of Philadelphia, in 2015. The grant for the study was awarded five years ago, back in 2014, and was supposed to start.
“And we have had delay after delay and we keep inquiring,” Carol Chittenden, with the Empire State Consumer Project, said.
Carol Chittenden is with the Empire State Consumer Project, an advocacy group that works to reduce toxins in our products and planet. She filed a petition to get the FDA to do the study. When 8News last checked on this, we were told it would get underway by the end of 2018.
8News followed up and found out that so far, CHOP has not enrolled anyone in the study. In a statement, 8News was told:
“We are actively working with the FDA to finalize the methods of this study and an announcement will be made once we begin enrolling patients.””It’s super frustrating,” Chittenden told 8News.
This as 8News has uncovered side effects, which the FDA describes as adverse events, linked to Miralax or peg 3350 have soared to more than 25,000.
“Quite frankly, I feel like the FDA, the hospital, they failed us,” Koehler said.
8News reached out to the FDA and were told, “We continue to work with CHOP on this. The assays required to analyze the data that will be gathered in the study raise novel scientific issues and have proven challenging to develop. FDA is providing additional assistance to try to facilitate the development of these assays so that the study can be completed as soon as possible. In the interest of greater transparency, we have asked CHOP to provide more frequent updates on the study’s progress, including assay development.”
In the meantime, 8News has been digging and we’ve learned of another study into PEG 3350 using mice. 8News confirmed that the study is underway but researchers said it would be premature to talk about it now but 8News will stay on it.