![]() ![]() It is approved and labeled for use in adults and children 17 years and older for up to 7 days, unless otherwise directed by a doctor.” We will submit our findings to the FDA upon completion of the study.”ĬBS News reached out to Bayer, the manufacturer of MiraLAX, which issued the following statement: “MiraLAX is a safe and effective osmotic laxative that relieves occasional constipation. We cannot comment on studies that are incomplete, nor can we comment on a particular child’s circumstances. “Researchers at Children’s Hospital of Philadelphia are conducting a study commissioned by the Food and Drug Administration on laxative-use by children. And that’s not because they’re not necessarily safe for use in children, it’s because the studies have not been done in a way that has led to FDA approval,” he said.ĬHOP issued the following statement in response to WPVI-TV’s report: “For pediatricians and pediatric sub-specialists, there are many treatments that we offer to children who have very serious symptoms that have not been approved by the FDA for use in children. He notes that although MiraLAX isn’t approved by the FDA for use in children, it doesn’t mean it is not safe. ![]() “My personal professional opinion is that I don’t think it’s likely that MiraLAX is causing these symptoms.” “It’s generally my recommendation to treat symptoms that are causing problems and not symptoms that are not causing problems,” he said. However, for children with chronic constipation for which alternative treatments have not worked, Mink says he believes MiraLAX is likely safe to use. “I think it’s important that the study is going on to look into this because the concern has been raised,” he said. Mink says he believes the study will eventually help provide more concrete answers. “However, because many parents and physicians rely on these products to treat serious constipation, we have decided to fund research to better determine the benefits and risks associated with the use of these products in children.” “To date, the agency’s reviews of adverse event reports and medical literature indicate that the approved labeling for PEG 3350 products accurately conveys their risks, and additional warnings regarding neuropsychiatric issues in children are not warranted at this time,” the FDA said in a statement. In 2014, the FDA reported 167 adverse side effects in children who had taken MiraLAX, 37 of which included neurological or psychiatric responses.īut after reviewing these cases, the agency said there was not enough evidence to change or add any additional warnings to the drug’s label. ![]() “Could this be an association where there’s no cause-and-effect relationship?” “The question is, then, is this a coincidence?” Mink said. That raises the possibility that problems the parents observed may have been due to an underlying condition rather than the medication itself. Though the exact connection is unclear, the nature of these disorders likely has something to do with it, as nerve cells and muscles also control bowel function, explained Mink, who serves on the executive committee of the American Academy of Pediatrics’ Section on Neurology and is president of the Child Neurology Society. “I see an awful lot of children who have neurobehavioral syndromes like Tourette syndrome, attention deficit hyperactivity disorder, autism, and anxiety and constipation is a common problem in those children,” he told CBS News. Jonathan Mink, MD, says that while the jury is still out, there are other likely scenarios that might explain the issues these parents reported. How great a concern are such claims, and is there proof that MiraLAX is the cause of the problems? ![]()
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