Children under two shouldn't be
given over-the-counter cold medications, even if they're
labelled for infants, warned Health Canada after reports
of several deaths.
"Before using over-the-counter
cough and cold remedies in children under two years
of age, Health Canada urges caregivers to consult a
health-care practitioner to assure that their use is
safe and appropriate," reads the October 11 release.
On the same day, manufacturers voluntarily recalled
some of those drugs.
But concerned physicians and patients
could simply checked the FDA website, in which case
they would have seen a similar warning two months ago.
Or they could have checked the websites of the Canadian
Paediatric Society or the American Academy of Pediatrics
and they would have seen almost identical warnings that
have been there for several years.
COLD
CASES
In January, the US Centers for Disease Control and Prevention
announced that three infant deaths had been linked to
cough and cold medicines. All three children were found
to have elevated blood levels of pseudoephedrine, while
two also had detectable levels of acetaminophen and
of the cough suppressant dextromethorphan. But the fact
that pseudoephedrine can menace an infant's heart will
surprise no pediatrician; the FDA and Health Canada
are not reacting to new clinical findings, but finally
acknowledging some very old ones, after a lot of nagging.
The latest warnings are the result
of a long-running campaign by the American Academy of
Pediatrics and several state public health authorities
to persuade the FDA to say what every pediatrician knows
about infant cough and cold medicines: they don't work
in infants.
Acetaminophen and ibuprofen do
work, of course, at controlling fever. What doesn't
work is the various decongestants, antihistamines and
cough suppressants that come with them. "Most have never
really been properly tested in young children," says
Dr Michael Rieder, professor of pediatrics at the University
of Western Ontario and a spokesman for the Canadian
Paediatric Society. "But what little evidence there
is suggests they don't really work." And if there's
no benefit, why tolerate even a small risk?
"When you look at the reporting
database, if you can glean any information from it,
which is not easy, you find that the actual deaths are
usually associated with the catecholine medicines, like
pseudoephedrine" says Dr Rieder.
CHILD
ETHICS
The reason so little is known about the effects of medicines
that have been given to millions of children is that
we don't generally test drugs on children. It's no coincidence
that so many of the recent post-approval recalls and
black box warnings have involved drug effects in kids.
But many experts contend the high
principles of research ethics committees are not protecting
children, they are simply ensuring that pediatric drugs
enter the market without proper testing. If placebo-controlled
trials are acknowledged, on balance, to save adult lives,
then surely the same would be true for children? "This
is really the great question of the day," says Dr Rieder.
"A lot of other countries, in Europe for example, are
reexamining their opposition to clinical trials in children.
I think we, too, are going to have to face this issue
soon."
WORDS
OF WARNING
At press time, FDA experts were sitting down to what
will be the decisive meeting on over-the-counter child
cold medicines, with definitive recommendations - and
maybe some recalls - to follow. Dr Rieder doubts that
the current advisory will be the last issued by Health
Canada on this subject, either.
In the meantime, here is an additional
warning not issued by either Health Canada or the FDA:
it is tempting to belittle foolish parents who give
inappropriate over-the-counter medicines like pseudoephedrine
for the common cold. The FDA implicated pseuodephedrine
in all three of the tragic examples provided by the
CDC. But read the small print, and you will find that
two of those infants actually got their pseudoephedrine
from a physician's prescription.
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