Maralix error9/16/2023 ![]() ![]() But this did not stop the company and is affiliates from allowing the drug to be taken by patients–under supervision from a doctor–whose medical history would put them at risk. The grant for the study was awarded five years ago, back in 2014, and was supposed to start.Since at least 2009, researchers have been aware that MiraLax, an over-the-counter laxative manufactured by Bayer Corp., is not safe for patients who suffer from kidney disease. 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. As Bayer is not involved in the study, any inquiries should be directed to them.” 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. Results of this ongoing monitoring support the continued safe use of MiraLAX. 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.Īs 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. OTC labeled dosing applies to adults and children 17 years and older for up to 7 days, unless otherwise directed by a doctor. MiraLAX was introduced as a prescription laxative in February 1999 and was approved by the FDA as an OTC medication in 2006. Miralax is an osmotic laxative that relieves occasional constipation. The MiraLAX® brand became part of Bayer’s OTC portfolio in the United States in October 2014 with the acquisition of Merck Consumer Care. The health of our consumers is our top priority. 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.īayer 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. “If you would get too close to her, she would hit you, she would bite you, she would pinch.” “She would have these uncontrollable tics,” said Norma Eggleston. Norma Eggleston told 8News her granddaughter Carmen experienced nervous tics and aggression when she was prescribed Miralax daily for her chronic constipation. Some families now believe it’s triggering neuro-psychiatric issues in their children. Yet 8News has uncovered doctors commonly prescribe the laxative to infants and young children. ![]() ![]() While Miralax has lined pharmacy shelves for decades, if you read the label you’ll see it’s not recommended for children under 17. 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. Koehler, who talked to 8News from Wisconsin over Skype, is disturbed and disappointed to learn a study into Miralax has yet to begin. “You know quite frankly I am feeling a little betrayed,” said Mike Koehler. ![]() 8News first reported on the concerns last year when a study into the issues was promised.ĨNews 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 (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. ![]()
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