A Food and Drug Administration advisory panel voted Friday
to ban popular over-the-counter cold products intended for children
under the age of 6.
The panel found there
was no proof that the medicines eased cold symptoms in children, while
there are rare reports that they have caused serious
If put into practice, the ban could transform pharmacy shelves and
change the way parents cope with the most common illness in young
children. The vote comes a week after major manufacturers agreed to
withdraw more than a dozen cold products labeled for use in infants
But manufacturers said they would fight the new
"We believe these
products will remain on the market," said Linda Suydam, president of
the Consumer Healthcare Products Association, a trade
A forced withdrawal might take years to carry out, top drug agency
"We need to go back and review all these recommendations that we
heard today and decide what the path forward might be," Dr. John
Jenkins, director of the office of new drugs at the agency, said after
If the agency decides to adopt the committee's recommendation, it
must undertake a rule-making process that can "take anywhere from
one to many years," Dr. Jenkins said.
While the panel voted, 21 to 1, to ban over-the-counter pediatric cold
products for use in children under 2, its vote to ban them for 2- to
5-year-olds was 13 to 9. The F.D.A. usually follows the advice of its
expert panels, but the closer the vote, the more likely the agency is
to ignore it.
Dr. Joshua Sharfstein, Baltimore's commissioner of health and a
co-author of a petition that led to the F.D.A. review of the safety of
the medicines, said drug makers and the agency should agree to a quick
end to the marketing of cold medicines for children under 6.
"After the advisory committee's clear vote, there is no
justification for formulations of these products geared at toddlers or
depicting small children," Dr. Sharfstein said.
Whatever the outcome in the marketplace, the panel's advice for
parents was clear. They should not use over-the-counter cold medicines
in young children.
Dr. Jenkins's own advice to parents was less forceful. "Parents as
always should carefully follow directions," he said. "They should
pay close attention to ingredients to make sure they don't use the
same ingredients from multiple products."
The products under review include such common brand names as
PediaCare, Robitussin and Triaminic, which are made, respectively by
Johnson & Johnson, Wyeth and Novartis. Some of these products are
directly marketed for toddlers and other children under 6.
Ms. Suydam told the panel that pediatric cold medicines were safe and
effective, that many of the problems associated with the medicines
came from unintentional overdoses and that an educational campaign
could resolve most problems.
The panel largely rejected these arguments, voting overwhelmingly that
there is no evidence that over-the-counter pediatric cold medicines
have any effect on symptoms and that more studies must be done. Still,
nine panel members voted against an outright ban in children ages 2 to
5, arguing that doctors and parents need something for ill children,
even if it has no proven effect.
Amy J. Celento-Stamateris, a patient's representative on the panel
from Nutley, N. J., said she was worried that a ban would lead parents
to give their children products intended for adults, increasing the
risks of overdoses.
"I'm not going to name names among my acquaintances," Ms.
Celento-Stamateris said. "But people do use these medications to
make their children get some sleep."
But most panel members said that if the drugs had not proven to be
effective in young children, they should not be
"Products for children under 2 were withdrawn from the market, and
the world didn't come to an end," said Sean P. Hennessy, a panel
member from the University of Pennsylvania School of Medicine. "Us
saying that they should still be used in the absence of efficacy data
knowing that they cause risks would be irresponsible."
There are about 800 pediatric cold products sold in the United States
that use one or more of 39 different drugs. Parents spend around $500
million every year buying nearly 95 million boxes containing 3.8
billion doses of medicine.
The panel voted, 15 to 7, to allow the continued marketing of
medicines intended for children 6 and older. It voted unanimously to
require standard measuring devices across products to cut down on
"You can take a cup from one item and place it on a totally
different drug without the family recognizing it," said Michael R.
Cohen, a panel member and president of the Institute for Safe
Medication Practices in Huntington Valley, Pa.
The panel also voted that no product should be allowed to market
itself as "doctor recommended," a common pitch that many panelists
The American College of Chest Physicians recommends that these
products not be used in children. Dr. David I. Bromberg, a district
vice president for the American Academy of Pediatrics, told the panel
that his organization believed that the product labels should warn
parents that they were ineffective and, in rare instances, dangerous
in children under 6.
"The current labeling of these products is therefore inaccurate,
inadequate and dangerous," Dr. Bromberg said.
Pediatric cold medicines were approved in the early 1970s despite
almost no evidence that they worked because regulators assumed then
that drugs that worked in adults would also be helpful in children.
Since then, researchers have learned that adults and children can
react to medicines very differently.
Ms. Suydam said manufacturers would immediately begin studies of the
medicines, nearly all of which lost patent protection decades ago. Any
money that companies spend on studying unpatented drugs also benefits
competitors that spend nothing.
Daniel A. Mannello of Largo, Fla., told the committee that the
pediatrician for his son, Dennis, suggested that he be given Dimetapp
as an infant and that the medicine caused scarring in the boy's
brain that has led to chronic seizures. Dennis, now 9, is facing brain
surgery to relieve the debilitating condition. Dimetapp has since been
"Please do the right thing and remove these drugs from the shelves
immediately," Mr. Mannello said.
Dr. Geoffrey L. Rosenthal, a panel member who works at the Pediatric
and Congenital Heart Center at the Cleveland Clinic Children's
Hospital, said pediatric cold medicines could be particularly
dangerous for children with unrecognized congenital heart
"In my pediatric
cardiology practice, we uniformly suggest that patients avoid these
medications," Dr. Rosenthal said.
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