| BELTSVILLE, Md.
BELTSVILLE, Md. Oct 2 Over-the-counter cough
and cold medicines should not be sold for young children
because they are unproven and can be dangerous, doctors and
consumer advocates said on Thursday, despite objections from
Experts urged U.S. Food and Drug Administration officials
to ban sales of the products, which include versions of Wyeth's
WYE.N Dimetapp and Procter & Gamble Co's (PG.N) NyQuil, for
children ages 2 to 6.
Other products also include Novartis AG's NOVN.VX(NVS.N)
Triaminic and Johnson & Johnson's (JNJ.N) Tylenol and
PediaCare, among others.
"Cough and cold medications ... have not been proven to be
effective and they have clear risks. It is time for them to be
reevaluated," Dr. Wayne Snodgrass of the University of Texas
Medical Branch, said at an FDA meeting to discuss whether the
nonprescription remedies should be sold for children.
Such products have been sold for decades and aim to combat
runny noses, coughs, congestion and other symptoms. But they
can potentially increase the risk of stroke, seizures and other
complications, often because of dosing errors.
They also have never been proven to work, the doctors
In January, the FDA recommended against their use in
children up to 2 years old and products aimed at that age group
have been recalled. It is still deciding whether to take action
for children of other ages.
An FDA panel of outside experts last year said
nonprescription cough and cold medicines should not be given to
children under age 6.
Unlike some children's medicines, these drugs were allowed
on the market under special rules for over-the-counter products
that do not required data showing safety and efficacy. Instead,
data were extrapolated from adults.
Industry representatives rejected the concerns, saying cold
medicines are safe for children over 2 years old when used as
Without them, parents may turn to inappropriate adult
products or simply try alternative treatments that could be
risky, Linda Suydam, head of the Consumer Healthcare Products
"We know from real world use ... that serious adverse
events are rare," said Suydam, whose group represents over-
Companies are launching several studies to look at
individual ingredients, she added. They are also trying to
educate parents and improve packaging to help parents properly
Roughly 95 million packages are sold in the United States
each year, according to CHPA, which did not have sales figures
for the industry.
There is no cure for the common cold, but parents often
feel pressured to use a product to help their sick child feel
better, some physicians said. And while the American Academy of
Pediatricians now rejects use of such remedies, some doctors
still suggest them.
But Dr. Janet Serwint, a professor at Johns Hopkins
University, said attitudes among parents, newer doctors and
medical students are changing.
"I think parents really don't want to give their children
medication," she told the FDA.
The FDA had said it planned to issue an opinion on children
ages 2 to 6 earlier this year, but in August asked for more
information and announced a public meeting.
The agency could change its rules to further restrict use
of the products in children, a process that could take years,
or it could require the products to go through a new approval
process requiring clinical trials. Officials also could issue
an advisory with recommendations for parents.
But doctors and advocates said the agency already knows the
drugs have never been proven and has had years to act.
"It's a problem of lack of will," Diana Zuckerman,
president of the National Research Center for Women & Families,
said in prepared comments for the agency.
(Reporting by Susan Heavey; Editing by Andre Grenon)