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FDA Reviewing Cold Drug Safety in Kids

Special Focus on Safety in Infants Less Than 2 Years Old

FDA Responds to Petition continued...

Ganley said the drugs' effectiveness in children was extrapolated from adult efficacy studies and had been reviewed by an expert panel.

But the drugs haven't been studied in children.

"It's incredibly difficult to be able to establish efficacy with these types of studies in children," Ganley said.

"If you're going to require that they have to have a study in children that statistically shows a significant difference between the active drug and a placebo, then you're essentially going to have no products available to treat respiratory symptoms in children," he said.

"It's a much more complicated issue than saying the therapeutic dose is not correct and it's leading to all these adverse events," Ganley said.

"In some situations, this issue is related to what's administered and how much is administered, and it may not be following the instructions on the label," he said.

Trade Group Responds

The Consumer Healthcare Products Association (CHPA) issued a statement about the safety and effectiveness of over-the-counter (OTC) cough and cold medicines.

In the statement, the CHPA notes that millions of Americans use OTC cough and cold products every year.

The CHPA also stresses the importance of following label instructions. "It is worth noting that the labels of all cough and cold medicines for children direct parents and caregivers to contact a physician before giving to a child under 2 (at a minimum)."

"The makers of all medicines welcome the opportunity to continue working with the FDA to ensure consumers have access to the safe and effective medicines they rely on," it states.

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