Wednesday, April 04, 2007
A Spoonful of Trouble
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Purple grape. Bubble-gum pink. Neon cherry red. The cough and cold aisle in my local CVS looks more like a candy counter than a drugstore. Yet the medicines found here in cartoon-baby-emblazoned boxes are a godsend for exhausted parents of cold-ridden kids. Or are they? Just a few days ago, I would have said confidently that spoonfuls of such elixirs indubitably help kids feel better. But after a bit of research, my confidence has crumbled. According to a recent CDC study, a March petition from a group of prominent pediatricians, and years of warnings from doctors’ groups, cold medicines for kids not only don’t work, they are also not as harmless as the marketers will have you believe.
Then why the heck do they crowd shelves in every pharmacy in this country? For one, the market is clearly there - the average child suffers 6 to 10 colds per year, and each cold lasts 10 to 14 days, resulting in sleepless nights for both child and adult. But they are on the shelves in the first place because of a sort of grandfathering effect. Back in 1962, the federal government passed an amendment stating that all drugs must be proven safe and effective. Existing over-the-counter drugs – including cough and cold medicines – went through a somewhat abbreviated re-approval process that included expert evaluation of research, clinical opinions, and public comment. The recent petition from the pediatrician group says that the FDA was never able to fully evaluate the safety and efficacy of cough and cold meds in kids because no good studies existed. Yet, the drugs still became labeled “Generally Recognized as Safe.” (Later, the FDA did recommend that these drugs not be marketed to children under 2.)
Since then, a handful of studies has shown that these drugs might not do what they are labeled to do. A 1997 study in 59 pre-schoolers aged 6 months to 5 years found that an antihistamine-decongestant combination didn’t relieve cold symptoms any better than a placebo, though it did make the kids sleepier. A 1991 study in 96 children aged 6 months to 5 years also found no benefit of these drugs. A 1993 study in 49 kids aged 18 months to 12 years showed that neither codeine nor dextromethorphan – anticough meds – relieved night cough better than a placebo. A few more studies found similar results.
And aside from not helping, these drugs may actually be hurting. A CDC study from January showed that an estimated 1,519 children under age 2 were treated in emergency rooms all over the country in 2004-2005 for problems or overdoses associated with cough and cold medications.
Doctors groups have tried for years to raise this issue. Back in 1997, the American Academy of Pediatrics issued a policy statement that parents should know that kids’ cough meds have no real benefit and pose a legitimate risk, emphasizing that dosages for kids are extrapolated from studies on adults with no consideration of a child’s unique metabolism and physiology. In their 2006 clinical practice guidelines, the American College of Chest Physicians also said that cough suppressants should not be used in children.
The reason for the oversight could be that the FDA has so little time and money to carry out a tremendous agenda, and it also doesn’t have the resources to conduct independent studies. Plus, these medicines have been such a generally accepted part of American culture for years, it almost seems silly to re-examine them. But in March, that’s exactly what that group of pediatricians demanded the FDA do. The FDA responded that it would indeed begin a review of the situation.
So what’s a concerned parent to do when his or her little one is up all night, as stuffed as an Easter turkey, coughing his stomach lining out? Most of the time, these drugs are safe when taken at recommended doses. Yet problems do pop up, and overdoses can occur, especially when parents give kids different drugs with overlapping ingredients, inadvertently increasing the dosage of a particular component. In the end, it makes sense to avoid giving cough and cold medicines to kids under 6 and asking your doctor about older children (be sure to list every single prescription, over the counter, and herbal medicine your child takes). As a last resort, experts recommend using saline nose drops or a cool mist humidifier to soften mucus, and a rubber suction bulb to clear it out. Back to the sleepless nights…
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