JUST SAY NO TO COLD
DRUGS: FDA warns
parents again never to give
over-the-counter cold
medications to kids under two
years of age.
The Food and Drug Administration
this week issued a stern health
advisory once again warning parents
not to give babies under two years
of age over-the-counter (OTC) cold
and cough medicine because of
potentially "serious and
life-threatening side effects." This
includes decongestants,
expectorants, antihistamines and
antitussives (cough suppressants)
that you can pick up at pharmacies
and supermarkets, including Wyeth's
Robitussin, Novartis, AG's Triaminic
and Johnson & Johnson's Tylenol Plus
Cold.
"The FDA strongly recommends to
parents and caregivers that OTC
cough and cold medicines not be used
for children younger than two,"
Charles Ganley, director of the
FDA's Office of Nonprescription
Products said. "These medicines,
which treat the symptoms and not the
underlying condition, have not been
shown to be safe or effective in
children under two."
The announcement comes on the
heels of a high-profile meeting last
October at which experts warned of
dangerous side effects in children
and recommended they not be given to
those younger than six years old.
Besides fatalities, adverse effects
reported include convulsions, rapid
heart rates, and reduced levels of
consciousness.
The FDA noted in its public
advisory that it is "aware of
reports of serious side effects" in
children between two and 11 years
old, but is still reviewing
information about risks in that age
group. The agency in August warned
parents not to give over-the-counter
cough and cold remedies to tykes
under two years old, but issued the
current alert because it was worried
parents did not get or heed the
message.
After last year's huddle, many
drug companies voluntarily pulled 14
cough and cold products targeted at
toddlers from store shelves. The FDA
in the past has not required
pharmaceutical manufacturers to
prove the elixirs, which have been
sold for decades, work in children,
allowing dosing to be gleaned from
adult data. But pediatricians have
been increasingly concerned about
the safety of these products in
their young patients.
"Children metabolize and react to
medications differently than adults,
often in unanticipated ways,'' the
American Academy of Pediatrics said
in a statement released after the
FDA alert. "Studies have shown cough
and cold products are ineffective in
treating symptoms of children under
six years old and may pose serious
risks.''
Physicians have suggested using
old-fashioned remedies to help ease
cold symptoms, including drinking
lots of fluids (among them, Mom's
favorite chicken soup), humidifiers
and rubbing babies' backs in a
steamed-up bathroom.
The FDA is expected to rule by
the spring on whether the drugs
should also be nixed for kids
between the ages of two and 11. In
the meantime, it cautions parents
who use them in that age group to,
among other things, carefully follow
dosing directions, only use
measuring spoons or cups that come
with or are specifically designed to
be used with the drugs, and remember
that the drugs, at best, temporarily
mask symptoms of but neither cure
nor shorten the duration of colds or
coughs.