FDA Wants More Time to Study Cold Meds for Kids

And the U.S. Centers for Disease Control and Prevention reported that some 7,000 American children under the age of 11 are treated each year in hospital emergency rooms because of problems with cough and cold medications.

At Thursday's hearing, Dr. Alejandro Necochea, a research associate with Public Citizen's Health Research Group, called on the FDA to immediately ban all OTC cough and cold medicines for children under 12, saying kids who take the drugs do no better than those who take no drugs at all.

"In the absence of direct evidence that a product is effective, no amount of toxicity is acceptable," Nocochea said. Reports of serious adverse effects linked to these medications include convulsions, rapid heart rates, decreased levels of consciousness and death, Necochea said in a news release issued by Public Citizen.

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According to Dr. Michael Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital, the recent debate originally stemmed from a lawsuit by a group of pediatricians who felt that cough and cold medicines were unsafe -- or at least never proven to be safe. This led to the FDA's statement earlier this year regarding young children.

Spigarelli planned to testify at the hearing. "The current hearings are looking at a wider pediatric age range," he said.

Chanin Wright, an assistant professor of pediatrics at Texas A&M Health Science Center College of Medicine, said: "If the FDA takes those medications off the market, the impact on the public is unknown at this point. There's a risk that the parents would turn to adult formulations for their children which could potentially cause harm. I don't think the FDA wants that, so they're asking expert opinion."

In addition to considering whether these medications should be over-the-counter or prescription, the hearings will cover a wide swath of territory, including questions of dosing and age range.

One of the most provocative issues is that of testing: What types of studies, if any, should be conducted in children and how should these studies be designed and powered?