FDA: No Cold, Cough Medicines for Babies
FDA Rules That Over-the-Counter Cough and Cold Medicines Shouldn't Be Given to Kids Younger Than 2
Jan. 17, 2008 -- The FDA today urged parents and caregivers
not to give over-the-counter (OTC) cough and cold medicines to
children younger than 2 because of dangerous side effects.
"We strongly recommend that
over-the-counter cough and cold products should not be used in infants and
young children under 2 years of age because serious and potentially
life-threatening side effects can occur from use of these
products," Charles Ganley, MD, director of the FDA's Office of
Nonprescription Products, said at a news conference.
OTC cough and cold products
include decongestants, expectorants, antihistamines, and antitussives (cough
suppressants) for the treatment of colds.
An FDA news release states that
rare, serious adverse events -- including convulsions, rapid heart rates,
decreased levels of consciousness, and
-- have been reported with use of cough and
The FDA is still reviewing
the use of cough and cold medicines in children aged 2-11.
Today's FDA recommendation is
in line with the findings of an
FDA advisory panel that weighed in on the topic last October, shortly after
makers of OTC cough and cold drugs for infants voluntarily
products off the market.
A key concern has been the
potential for accidental overdoses if the dosing instructions for those drugs
aren't followed exactly as instructed.
"I will point out that the FDA
has never endorsed the use of these products in children less than 2 years of
age," Ganley says. "We've always acknowledged that there was no
safety and efficacy data. It was really left to the discretion of health
providers to determine whether use of one of these products was appropriate in
these age groups."
Ganley says the FDA decided
to issue today's advisory after learning of recent surveys that show that
some parents aren't aware of the warnings issued last fall about the use of
OTC cough and cold drugs in kids younger than 2.
"This announcement will bring
this issue back into the public consciousness, particularly since it's cold
season now," Ganley says.
The Consumer Healthcare Products Association (CHPA), a trade group
representing makers of over-the-counter (OTC) medicines, issued a statement
supporting today's FDA's decision.
"Safety has always been and continues to be our top priority," says
CHPA President Linda Suydam, DPA.
"Today's decision by the FDA reaffirms the correct course of action
taken by the leading makers of these medicines last fall," says Suydam,
referring to the voluntary withdrawal of over-the-counter cough and cold drugs
The CHPA is working with retailers, doctors, and the FDA "to ensure that
parents have the tools they need to safely and appropriately administer OTC
oral cough and cold medicines to children over the age of two," Suydam
Tips for Parents of Older Kids
Speaking at today's FDA news
conference, Lisa Mathis, MD, associate director of the FDA's Pediatric and
Maternal Health Staff in the Office of New Drugs, reminded parents that the
FDA hasn't finished reviewing cough and cold drugs for older