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Bad medicine

An FDA advisory on cold and cough treatments for toddlers is welcome, and changes are needed.

August 17, 2007

In the it's-about-time department, the Food and Drug Administration is finally taking a close look at the scientific reality behind all those TV commercials showing snuffly, coughing toddlers whose symptoms are erased by doses of over-the-counter medications delivered by loving parents. On Wednesday, the agency warned parents not to give children under 2 those medicines and announced that it would hear from experts in October to discuss whether to go further.

At least the loving parents are still an essential ingredient for soothing a child's unhappy moments. As for the decongestants and cough suppressants, studies have found for years that they have dubious value to anyone but their makers, which sell more than $2 billion worth a year.

According to a 2001 article in the journal Pediatrics, "Although they may alleviate some symptoms in adolescents and adults, many studies have demonstrated that OTC cough and cold preparations do not achieve such claims in the younger pediatric population." A January 2007 report by the Centers for Disease Control and Prevention that focuses on children younger than 2 likewise concludes that the medicines "are not more effective than placebo in reducing acute cough and other symptoms of upper respiratory tract infection." Earlier, the American College of Chest Physicians had issued new treatment guidelines, saying that children 14 years old and younger shouldn't take the medications because they're ineffective and could prove harmful. And in its report on infants younger than 2, the CDC found that in 2004 and 2005, U.S. emergency rooms treated more than 1,500 such children for "adverse effects" associated with the medications. Three babies died.

The medicines are generally safe when given as directed. But the potential for overdose is high. For one thing, when the medicines don't work, parents might assume they haven't given a large enough dose. Different caregivers might give the same child medicine, not realizing the child recently had a dose. Or parents give their children more than one preparation -- one for the sniffles, say, and one for the cough -- unaware that ingredients might overlap.

The over-the-counter medications were approved for children based on old FDA formulas that involved little more than extrapolating from adults. In other words, if the medicines worked for adults, they were presumed to work for children. Doses were based on the typical child's weight as a percentage of adult weight. For children younger than 2 years, the labels direct parents to seek a physician's advice. Unfortunately, doctors have little information on which to base that advice; the FDA has no dosage guidelines for that age group.

The remedies have been long overdue for the kind of updated review that the FDA promised to do decades ago on older drugs. It has made little progress on that promise, but the agency should move quickly on this one. It should at least require changes in labeling that give parents the full information up front and in large type, and prohibit marketing the formulas for use on the youngest, most vulnerable patients.

Any medication involves some level of risk that must be weighed against the medicine's benefits. But how many parents would be willing to take any risk if they knew a placebo would work just as well? More likely, they'd fill a medicine dropper with that ancient decongestant, chicken soup -- which at least one study has found effective against colds. Side benefit: Overdoses are pretty much impossible.

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