Last week an FDA advisory committee recommended that the agency stop pharmaceutical companies from selling cough and cold remedies for children under 6. (The news accounts are unclear on this point, but I assume the recommendation also covers over-the-counter allergy medications, which contain some of the same antihistamines and decongestants that are the main cause of concern.) "From 1969 to 2006," the Los Angeles Times reports, "the FDA received 54 reports of child deaths associated with decongestants and 69 linked to antihistamines." That's about three deaths each year. Most involved children younger than 2, and manufacturers already have voluntarily removed cold medicines intended for babies and toddlers. More important, the deaths generally resulted from accidental ingestion or overdoses mistakenly administered by parents. The advisory panel faulted manufacturers for using inconsistent measurements and giving confusing dosage instructions. But if the FDA follows the committee's advice and bans cold remedies aimed at children younger than 6, it could make overdoses more likely, as parents estimate how much of a drug labeled for older kids should be given to a 3- or 4- or 5-year-old.
Although fatal reactions are rare and for the most part can be avoided by storing medicine safely and following the dosage instructions, the FDA panel concluded that any such risk is unacceptable because the products have not been shown to work in very young children. They have been shown to work in adults, however, and parents' experiences with their own kids' symptom relief suggests they work in children as well. Jesse Joad, a pediatrician who served on the FDA committee, dismisses such parental impressions. "They really believe it works," she says. "But colds are diseases that get worse for a few days and then get better. You don't have to give them anything." You don't have to give them anything, of course, but parents who want to minimize their children's discomfort may very well choose to. And if a child's nose stops running and he can breathe better shortly after taking an antihistamine/decongestant combo that has been shown to work in adults, and if this sort of thing happens consistently with different children, it probably is not simply a matter of the cold running its course.