Cough, Cold Medicine & Kids
October 18, 2007, 2:37 PM
If you're a parent, you might want to run a quick inventory of your medicine cabinet looking for over-the counter cough and cold medicines meant for children because the future of such remedies is being called into question by the FDA.
The issue being considered by the FDA's Advisory Committee is something pediatricians say they've known for years. Pediatrician Dr. Christopher Tolcher says, "We've known for a long time that cough and cold medicines in young children really aren't very effective."
But what's prompted the F-D-A hearing isn't how well these products work, it's the fear that they're not being used correctly. Tolcher says, "The poison control centers get hundreds of calls a year from parents of children that have been mis-dosed or over-dosed."
The result has proven deadly in 123 children over the past 35 years. Though today's testimony follows a voluntary recall by the drug makers of infant and toddler formulas, doctors are asking the FDA to rule that such over-the-counter medicines shouldn't be used in children under six either. Dr. Michael Shannon with the Harvard Medical School says, "When a treatment is ineffective, it's risks, unless there is zero, will always exceed its benefits."
Yet these medicines have been marketed for use in children for decades and add up to a whopping 50-million dollars in sales every year. That despite the fact that there is no data from studies in very young children to show they are both safe and effective. Dr. Joshua Sharfstein, Baltimore's Health Commissioner says, " The FDA did not approve these products based on the basis of evident of safety and effectiveness in Children."
For their part, manufacturers say the medicine is safe and insist their recall was issued out of a --quote-- abundance of caution. They say cases of children who died after taking the medicine were often the result of misuse or overdose. Dr. Dan Levy, president of Maryland's chapter of the American Academy of Pediatrics says, "These are parents who think they're doing the right thing by giving these medications and, unfortunately, what happens is that we as pediatricians have to end up facing the consequences."
The panel of experts is expected to issue its recommendation late Friday. It will then be up to the FDA to decide what to do next.
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