Other News OTC cough/cold remedies are not for children younger than 4
By Sue Mueller
Oct 7, 2008 - 2:14:02 PM
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Tuesday Oct. 7, 2008 (foodconsumer.org) -- The manufacturers
of over-the-counter pediatric cough and cold medicines said today that parents
should not use OTC drugs in children younger than 4 years old.
The drug makers now volunteer to make the label to reflect
the new advice.
The Food and Drug
Administration has already advised that children younger than 2 years should
not use OTC cough and cold medicines.
Both the advices are not in agreement with the demand of physicians
and safety advocates. An FDA panel filed early a more than 360-page report
asking the FDA to ban use of OTC drugs in children under the age of 6 years.
Critics said there is no evidence to suggest the drugs
actually provide any benefits while evidence is abundant that these OTC cough
and cold medicines can do more harm than good.
Each year in the United States, about 7,000 children
under 11 go to emergency rooms after taking cough and cold medicines, according
to the CDC, cited by webmd.com although the majority of cases resulted from
unsupervised use of these medicines.
The Centers for Disease Control and Prevention reported
in March 2007 that "during 2004--2005, an estimated 1,519 children aged
under the age of 2 years were treated in U.S. emergency departments for adverse
events, including overdoses, associated with cough and cold medications."
Last week, the FDA held a hearing on the issue, but said
it will not take any action any time soon because it needs more data on
efficacy and safety to decide whether to ban these drugs or make them
prescription drugs or anything else.
The problem is that trials are few that have been ever
conducted to demonstrate the efficacy and safety, according to news media
reports.
The drug makers said they consulted with the FDA for the
new proposal. It seemed that they want to do something just to relieve some
burden now the FDA is facing.
Critics said if what happened with OTC cough and cold
medicine happened with alternative medicines or herbal medicines, the FDA may
have already banned the alternative medicines many times.
When children have cough and cold, physicians advise that
parents need not give their children any medication, let alone the OTC cough
and cold remedies.
Simply give them some
chicken soap and have them have a good rest.