Docs Support FDA Cough Medicine Warning

Cough medicines are one of a number of products whose safety profiles have been tested on adults, but not on children -- a concern reiterated in March by Dr. Charles Ganley, director of the FDA's office of nonprescription drug products.

Sharfstein was also part of the group of doctors that petitioned the FDA to review the products on the grounds that they haven't been specifically evaluated for safety and effectiveness in this age group.

"What we're asking is for these products to be held to a reasonable standard of safety and efficacy [for children]," he said. "To the extent that there is evidence in kids, the evidence is that they don't work."

Pediatricians Urge Caution

The warnings about cough and cold remedies are being echoed by many pediatricians, who note that parents may not be aware of possible adverse effects.

"In proper doses it is not dangerous, but some parents don't know what proper doses are," Dr. Lisa Thornton, a pediatrician at Children's Hospital in Chicago told ABC News medical editor Dr. Tim Johnson on ABC News Now's "Healthy Life" program Thursday.

Part of the confusion over dosing, she said, has to do with the fact that the amount of the drugs taken by the child should be measured according to the child's weight rather than their age, since children of the same age can vary drastically in terms of weight.

However, current dosing recommendations for the product are, in fact, based on a child's age.

"What we discuss with parents is that these medicines do have dangerous side effects, even though they are sold over-the-counter," Thornton said. "Pediatricians need to stress to parents that these are medicines that are not without side effects."

Alternatives to the Bottle and Spoon

Thornton noted that there are several drug-free ways to sooth a child's cough.

Parents may want to place a vaporizer in the child's room, or have the child take a hot shower, as the steam may soothe their throats and sinuses. Even spending time with a child as they fall asleep can often help relax children when they are uncomfortable.

And as for the medicines, it is still unclear whether the Oct. 18-19 meeting will yield new regulations. However, Sharfstein said he is optimistic.

"I think it is very encouraging that this is going before an advisory committee," he said. "It's a mechanism for the FDA to really shift tracks on how it's treated these products."

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