FDA Reviewing Cold Drug Safety in Kids
Special Focus on Safety in Infants Less Than 2 Years Old
WebMD News Archive
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
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.