Cold medicine warnings have benefited kids

Let's face it, a kid with a cold is no fun. Parents of babies, in particular, have it rough because tiny tots can't tell us just what hurts or what's stuffy and the congestion sounds so miserable that you want to make it go away.

That, of course, was the plan for many parents who have tried, with varying degrees of success, to minister to toddlers and younger with over-the-counter pediatric cold and cough remedies.

But for several years now, the labels on kids' cold medicines have sternly warned against giving them to anyone under age 4. Age 2 was the first cutoff decreed by the Food and Drug Administration and pediatricians in 2007, with the older group added a year later.

The concern then, and now, was that the medicines had not been adequately tested for safety and effectiveness in young children and that the products carried too great a risk of adverse events from overdose or side effects to justify continued use.

A recent analysis of emergency room data by scientists at the federal Centers for Disease Control and Prevention suggests that the ban has had a positive effect. The researchers looked at youngsters treated for problems related to cold and cough medicines during a 14-month period before the ban and a similar timeframe afterward.

They found that fewer than half as many children were seen in the period after the change in product labels than before (1,248 versus 2,790). And they found that adverse effects attributed to the medicines on children younger than 2 declined from 29 percent to 11 percent among 63 hospitals participating in a national injury surveillance network.

The study, published in the journal Pediatrics, also noted that there had been no notable uptick in problems related to parents giving babies pain medicines or antibiotics rather than the cough and cold remedies, a fear expressed by some experts before the label change.

But the study also showed that the overall number of ER visits related to cold and cough medicines among kids younger than 12 didn't decline by much, dropping to 9,408 from 9,727 before the first label change. Another review will be needed to measure the effect of the 2008 ban, researchers said.

Before and after the withdrawal, most of the visits were among children between 2 and 5. About two-thirds of those visits resulted from children taking the drugs on their own, without adult supervision, which the researchers suggest might be reduced by better childproof packaging.

However, a second study published last month in the Journal of the American Medical Association illustrated another danger from all children's over-the-counter drugs delivered in liquid form: dosing instructions that don't match measuring cups, spoons or syringes provided with the product.

Researchers at New York University School of Medicine examined the 200 top-selling pediatric liquids for pain, cough and cold, allergy and intestinal problems and found that only 148 had packaged a standardized measuring device with them. Of those products, more than 98 percent had at least one problem with either the dosing directions or with the measuring device markings not matching. Almost every product had problems with non-standard measurement abbreviations or abbreviations that were not defined.

Directions used a unit of measure that didn't match those found on the enclosed device in 89 percent of products that came with the medicine. And 81 percent of the devices had extra marking points that didn't match any recommended dose.

The study was completed just a month before the FDA in November 2009 issued new guidelines to the pediatric over-the-counter drug industry aimed at reducing the risk of unintentional overdoses that the agency says are often the result of bad directions or measuring devices. Those guidelines, however, are voluntary, meaning manufacturers have no legal obligation to follow them.

The NYU team said its findings offer a baseline for future assessments of what changes manufacturers and distributors are making to improve the labels and measuring devices.

In the meantime, parents who are unclear about what the instructions or dose markings on their child's medicine mean might want to double-check with a pharmacist, doctor or nurse to ensure the best results from that spoonful.