The FDA is considering an OTC cold medicine don't-use recommendation up to age 6.
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You won't find formerly popular cold remedies made for infants and young children on the shelves of your neighborhood pharmacy. The Food and Drug Administration recommended the products be removed if they were designed for children 2 and younger last October. Some manufacturers had already voluntarily pulled them.
The over-the-counter remedies don't offer the littlest cold sufferers anything in the way of relief, according to research. No benefit was shown in children up to 6 years old. And they pose a real risk of complications and overdose. The exception to the don't-use rule is when a health-care provider gives specific instructions and a reason to use the product.
"The bottom line is, there is little you can do to improve symptoms related to a cold," says Dr. Jeff Schunk, chief of pediatric emergency medicine at Primary Children's Medical Center.
"If the OTC drugs were particularly effective, they would have caught on and would have a place, with the safety issues. But it's difficult to treat colds and coughs. The medications are not particularly effective for little people. Many adults at least feel some relief. With children, it has been impossible to demonstrate improvement over a placebo. So you're left with treating symptoms."
Whether the remedies work for older kids those 2-11 is still in question. And there have been cases reported of serious side effects from cough and cold medicines in that age group, including overdoses.
"The American Academy of Pediatrics is working hard to dissuade physicians from recommending and parents from using OTC cold medicines in children less than 6. It's based partly on safety and partly on lack of effectiveness," Schunk says. "That gets to the heart of the problem. When you're doing something that doesn't give benefits, it leads to overdosing. We all want to do something to make children feel better. If any of those things worked really well, there wouldn't be 20 or 30 to choose from at the grocery store. You can't fault physicians and families from wanting to help. But the complications end up in emergency care."
The American Academy of Pediatrics says that more than 7,000 pediatric emergency department visits across the country were made by children 11 and younger who used a cough or cold medication.
The FDA is considering a similar don't-use recommendation up to age 6. They promise a decision this spring.
But the questions remain: What do you do when your baby is having trouble breathing or is fussing with a fever or cough? And how do you make sure you don't accidentally give your older children something that will cause a complication or overdose?
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