![]() ![]() “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? ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |