FDA Panel: Cold Meds Should Not Be Used for Kids Aged 2 to 6
Friday, October 19, 2007

WASHINGTON -  Cold and cough medicines don't work in children and shouldn't be
used in those younger than 6, federal health advisers recommended Friday.

The over-the-counter medicines should be studied further, even after decades
in which children have received billions of doses a year, the outside experts
told the Food and Drug Administration. The FDA isn't required to follow the
advice of its panels of outside experts but does so most of the time.

"The data that we have now is they don't seem to work," said Sean Hennessy, a
University of Pennsylvania epidemiologist, one of the FDA experts gathered to
examine the medicines sold to treat common cold symptoms. The recommendation
applies to medicines containing one or more of the following ingredients:
decongestants, expectorants, antihistamines and antitussives.

The nonbinding recommendation is likely to lead to a shake up in how the
medicines - which have long escaped much scrutiny - are labeled, marketed and
used. Just how and how quickly wasn't immediately clear.

In two separate votes, the panelists said the medicines shouldn't be used in
children younger than 2 or in those younger than 6. A third vote, to recommend
against use in children 6 to 11, failed.

Earlier, the panelists voted unanimously to recommend the medicines be studied
in children to determine whether they work. That recommendation would require
the FDA to undertake a rule-making process to reclassify the medicines, since
the ingredients they include are now generally recognized as safe and
effective, which doesn't require testing. The process could take years, even
before any studies themselves get under way.

Simply relabeling the medicines to state they shouldn't be used in some age
groups could be accomplished more quickly, FDA officials said.

Indeed, the drug industry could further revise the labels on the medicines to
caution against such use. The Thursday-Friday meeting came just a week after
the industry pre-emptively moved to eliminate sales of the nonprescription
drugs targeted at children under 2.

Pediatricians pushing for greater restrictions told the FDA advisers Thursday
that the over-the-counter medicines shouldn't be given to children younger
than 6, an age group they called the most vulnerable to any potential ill
effects.

But FDA officials and panelists agreed there's no evidence they work in older
children, either.

Still, panelists held off from recommending against use in older children.
Some said they feared such a prohibition wouldn't eliminate use of the
medicines by parents.

"They will administer adult products to their children because they work for
them or feel they work for them," said the panel's patient and family
representative, Amy Celento of Nutley, N.J.

The drug industry says the medicines, used 3.8 billion times a year in
treating cold and cough symptoms in children, do work and are safe. It says
that more parent education is needed to avoid overdoses that in rare cases
have been fatal.

A group of pediatricians petitioned the FDA earlier this year seeking action
on the medicines.

An American Academy of Pediatrics official earlier Friday told the experts the
medications should be relabeled to tell parents they don't work in children
under 6 and may be dangerous.

"Why not label these products with what we actually know?" asked David
Bromberg, a Frederick, Md., pediatrician.

Some of the drugs - which include Wyeth's Dimetapp and Robitussin, Johnson &
Johnson's Pediacare and Novartis AG's Triaminic products - have never been
tested in children, something flagged as long ago as 1972 by a previous FDA
panel.

An FDA review found just 11 studies of children published over the last
half-century. Those studies did not establish that the medicines worked in
those cases, according to the agency.

For the most part, the results from tests in adults have been extrapolated to
determine whether the medicines work in children. But even that evidence is
"modest at best," said panel chairwoman Dr. Mary Tinetti of Yale University
School of Medicine. Indeed, all but one of the 22 panelists then voted to say
that extrapolation is unacceptable.

The panel also recommended drug makers provide standardized droppers with
their liquid cough and cold medicines. Experts had told the panel the
sometimes hard-to-use dosing devices contribute to parents unwittingly
overdosing their children.

Later Friday, the panel also was to examine whether the dizzying array of
medicines that combine multiple ingredients. The FDA wants to know if drug
makers should do away with the combo products.

One health expert told the panel that children catch five to eight colds each
year. Those colds don't necessarily require treatment beyond comfort measures
that don't involve drugs, said Patricia Jackson Allen, of the National
Association of Pediatric Nurse Practitioners.