FDA Reviewing Cold Drug Safety in Kids
Special Focus on Safety in Infants Less Than 2 Years Old
March 2, 2007 -- The FDA today announced it is reviewing the safety and
effectiveness of over-the-counter cough and cold medicines for children.
The review follows a CDC report of three babies who died in 2005 after
taking cough or cold medications.
The FDA's drug review began last year and will take several more months to
complete, says Charles Ganley, MD, director of the Office of Nonprescription
Products at the FDA's Center for Drug Evaluation and Research.
Meanwhile, the FDA says parents should strictly follow dosing instructions
on children's cough and cold medications and not give children adult
Ganley stressed that point in a news conference.
"There are millions of doses of OTC cough, cold drug products that are
used on a weekly basis by children very safely," Ganley said.
"Parents need to strictly adhere to the dosing directions," he
"If dosing directions are to ask your doctor or consult a doctor prior
to use in a specific age group, parents need to adhere to that. That allows the
physician to make a determination of whether the drug product is appropriate in
that age group," Ganley said.
Particular Concern for Babies
Ganley said there are "issues related to the safety of those
products" in children under 2 years old.
He said the FDA worked with the CDC on a January 2007 report that noted the
three U.S. infants (all 6 months or younger) who died in 2005 after receiving
cough and cold medications.
All three babies had what appeared to be high levels of a nasal decongestant
in their bloodstream.
In addition, 1,519 children 2 years old and under were taken to U.S.
emergency departments during 2004-2005 for side effects associated with cough
and cold medications, including overdoses.
FDA Responds to Petition
Ganley said the FDA got a reporter's call on Wednesday about a petition that
had not yet been submitted to the FDA.
The petition alleges that the effectiveness of cough and cold medications
hasn't been established in children aged 2-6 years, Ganley said.
WebMD asked the FDA for the petition. An FDA spokeswoman refused, saying
they had just gotten the petition and didn't have a copy to share.
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.