Panel: No Cold Medicine for Young Kids
Experts Say Drugs Are Ineffective, Potentially Risky for Children Aged 2-5
Oct. 19, 2007 -- A panel of government advisors recommended Friday that
popular over-the-counter cold and cough medicines not be used in children who
are 2 to 5 years old.
The recommendation comes on the heels of two days of meetings in which an
FDA advisory panel scrutinized the safety and effectiveness of cold medicines
The committee concluded that cold medicines have no effective use in
children. Reports of potentially dangerous side effects led drugmakers several
weeks ago to stop marketing cold and cough medicines for use in children under
"The sentiment is what the sentiment is here, and that is that they
shouldn’t be used," said Mary Tinetti, MD, a professor of medicine at Yale
University and chairwoman of the FDA’s Nonprescription Drugs Advisory
The panel voted 13-9 to recommend that cold medicines not be used in
children over 2 years old but under 6 years old.
Committee member Sean P. Hennessey, PhD, of the University of Pennsylvania
School of Medicine, said the over-the-counter cold medicines should not be used
in children "given that there’s no evidence of efficacy of the drugs and
there’s evidence of harm of the drugs."
A similar vote for children between 6 years old and less than 12 years old
There are hundreds of over-the-counter cold medicines using different cough
and pain relievers alone and in varying combinations.
The FDA is considering whether to ban the marketing of the drugs for use in
The panel also voted to urge the FDA to ban the use of phrases like
"doctor-recommended" on cough medicine packaging.
"I think from this day forward it has no credibility," said Marsha
D. Rappley, MD, chairwoman of the FDA’s Pediatric Advisory Committee.
"And if it is used, it is to mislead people."
At the same time, the panel said drugmakers should be allowed to continue
marketing cold medicines using combinations of drugs, if they can show the
drugs are safe and effective in children.
(Do you use cough
and cold drugs when your little one is sick? Tell us your
reaction to the new warnings on WebMD's Parenting:
Friends Talking message board.)
FDA Action Uncertain
FDA officials say they're unsure how long the agency would take to
issue public recommendations based on this week’s meetings.
A decision to restrict or ban the use of cough and cold medicines in
children could take years, says John Jenkins, MD, director of the FDA’s Office
of New Drugs.
"Our advice remains in general be cautious and aware of over-the-counter
medications. When you are using them, follow the directions carefully,"
Jenkins also says parents should take care not to use more than one product
containing the same ingredient. Such combinations have been blamed for some
drug overdoses in children.
Despite experts' conclusions that cough and cold medicines have never been
proven effective in pediatric patients, industry representatives maintain that
studies showing some evidence of effectiveness are out there.
"These products are safe and effective, and parents have depended on
them for decades," says Linda Suydam, president of the Consumer Health Care
Products Association, the trade group representing over-the-counter
"We believe these products will remain on the market," she says
Suydam’s group estimates that 95 million packages of cough and cold medicine
are sold in the U.S. each year for a total of $311 million.