|
| |
FDA Advisers: No Cold Meds for the Young
(AP) Concentrated Tylenol Infants' Drops Plus Cold & Cough, right, and Pedia
Care Infant Drops...
Oct 19 2007, 4:31 PM (ET)
By ANDREW BRIDGES
WASHINGTON (AP) - The cold and cough medicines long used by parents to treat
their children's runny noses and other symptoms don't work 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' (JNJ)s Pediacare and Novartis AG' (NVS)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 recommended the dizzying array of medicines that
combine multiple ingredients remain on the market - but only pending the
results of future studies to determine whether they work.
The panel also said cold and cough medicines should not be allowed to bear
"doctor-recommended" and similar statements. It wasn't immediately clear if
such a prohibition would be constitutional.
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.
|
|
Young
Living Essential Oils