Curbing Cough Syrup For Kids

Now, a group of physicians led by Joshua M. Sharfstein, Baltimore's health commissioner (and a pediatrician), is asking the FDA to request that the companies stop marketing them to children younger than 6. They argue that no risk is acceptable because there has been no convincing evidence of the remedies' effectiveness.

The manufacturers are trying to prove they work.

"We are pulling together the scientific data to reaffirm the efficacy of these products," said Linda Suydam, CHPA's president. "We know they're safe and effective because we have adult data."

Several experts said, however, it may be extremely difficult to prove the remedies relieve symptoms in children too young to describe their sensations in detail.

Hovering over the issue is the question: What would happen if the pediatric formulations of the medicines were pulled off the shelf? Would parents, faced with sleepless and symptomatic toddlers, reach for the adult formulation and pour out a guessed-at dose. "That is a concern for us," John K. Jenkins, the physician who directs the FDA's Office of New Drugs, said Thursday at a break during a day-long hearing on the drugs' use in children. "We do not want to do something . . . only to have unintended negative consequences. We could have an even worse situation."

Several pediatricians, from both medical school and community practices, spoke at the hearing on behalf of the CHPA. They said that without pediatric formulations of the drugs, parents might turn to more dangerous alternatives, including herbal products. Several feared the risk might be greatest in low-income or single-parent households, where staying home with a sick child is an especial hardship.

Sharfstein and several other pediatricians, including a representative of the American Academy of Pediatrics, said that parents will listen to advice. Several cited the huge drop in use of aspirin in children two decades ago after parents were warned it could cause the rare, often fatal Reye's syndrome.

Sharfstein told the FDA officials that calls to the Maryland Poison Center about children younger than 2 who had taken cough-and-cold remedies declined 40 percent in the first six months of this year compared with last. He said this was evidence that parents were following the advice to not give the medicines to children that young.

He acknowledged that the FDA would have a lot of consciousness-raising to do. But he said that shouldn't stop the agency.

"The marketing frankly preys on the guilt of the family -- 'This is something you should be doing for your kid. This makes you breathe easier, too,' " Sharfstein said.

"But you would have the pediatricians and the nurse practitioners standing with you," he added. "You have more authority than you realize to get parents to pay attention to the message you want."

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