Q & A: Children's Cold Medicines
Tuesday, October 30, 2007
What has prompted all the fuss about cold medications for young kids?
The Centers for Disease Control and Prevention reported in January that at least 1,500 children younger than 2 had complications from such products in 2004 and 2005; a Food and Drug Administration review found 123 children had died from decongestants or antihistamines between 1969 and fall 2006. The review of infant products was sought by a group of doctors led by a public health official who linked their use to the deaths of four Baltimore area children.
Did the FDA's expert advisers overreact when they warned against using the products in kids 6 and younger? What about these products is so dangerous to little kids?
It appears that most of the complications occurred when children were given more than the recommended dosage of a single medication or more than one medication containing the same active ingredient. Given the millions of doses of these medications that have been administered in the past 20 or 30 years, says Richard Gorman, chairman of the American Academy of Pediatrics (AAP) section on clinical pharmacology and therapeutics, the number of negative incidents has actually been relatively low.
The bigger question, he says, is whether the medications work well enough to warrant taking that small risk. Because these products have never been tested for efficacy in children, Gorman says, it's hard to weigh their benefits against their risks.
So you're saying, besides the safety issue, there's a question about whether these products do much at all to relieve kids' cold symptoms?
Why did the FDA permit the sale of potentially dangerous products for children for decades?
These products all contain combinations of decongestants, antihistamines and antitussives -- substances the FDA has long regarded as "generally safe and effective." But assumptions about their efficacy in children were based on data from adult testing. The medical community now knows that such extrapolation isn't appropriate and that direct testing on children would be needed to show efficacy and determine proper dosage.
What's the next step? Will the FDA ban over-the-counter cold products for kids 6 and younger? Will more cold products be pulled from drugstore shelves?
It's too soon to know. The FDA has not taken any action yet beyond its Aug. 15 warning to parents about giving these products to children younger than 2. (In early October, makers of 14 major OTC cough and cold products made specifically for babies voluntarily removed their products.) For ages 2 to 6, the advisory panel narrowly recommended against the use of cold medications; the agency is reviewing those recommendations. For ages 6 to 12, the panel voted not to suggest restrictions.
Cold products for children 2 and older remain on the shelves. The Consumer Healthcare Products Association, which represents the major makers of these drugs, has committed to work with the FDA to design new ways to test the medications on children, according to Elizabeth Funderburk, CHPA's director of communications. CHPA also is planning an education campaign for parents on the proper use and storage of children's cold medications.