Drug News FDA waiting to regulate OTC cough and cold medicines
By Sue Mueller
Oct 5, 2008 - 3:12:53 PM
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Sunday October 5, 2008
(foodconsumer.org) -- On Thursday, physicians and consumer advocates at a
public hearing asked the U.S. Food and Drug Administration (FDA) to ban
over-the-counter or OTC cough and cold remedies for children younger than 6 years
or make them prescription drugs.
And the
agency said it will take time for it to consider taking any action.
There has been no evidence that
these OTC cough and cold products help children under the age of 6 years and on
the contrary evidence is abundant that these remedies could pose life
threatening adverse events in children of this age group.
Last year, the FDA issued an
advisory to warn parents not to give OTC cough and cold medicine to children
younger than 2 years, but experts and consumer safety advocates said that was
not enough and there was no reason to keep those useless, yet potentially
dangerous products on the Market.
Dr. John Jenkins, who heads the
FDA's Office of New Drugs was cited by healthday.com as saying this time that the
agency needed more data on efficacy and safety of these OTC medicines for
children between 2 and 6 years to consider any action. But few trials have been
conducted for these medicines.
Health officials at the FDA said the
agency also is concerned that a swift ban, which has been supported by
pediatricians' groups, could prompt parents to give adult medicines to their
children.
But delay to take action is not the option
to the advocates.
In January, the FDA already
updated its health advisory that cold and cough preparations including
decongestants, expectorants, antihistamines, and cough suppressants, should not
be used in children younger than 2 years.
In Sep 2007, safety experts for the
FDA said in a 356-page report that the agency should ban all over-the-counter
cough and cold medicines for children under 6 because these OTC remedies are
neither effective nor safe for such young children.
Experts recommended that all cough
and cold medications be removed from the market and products such as droppers,
cups and syringes used for the products should be standardized to minimize the
risk of overdosing.
According to a report last year by
the New York Times, the reviewers concluded that there is little evidence to
indicate that these medicines are effective in helping young children and there
is sufficient evidence that these products pose a serious risk to young children.
The report was cited as saying that
at least 54 young children died after taking decongestants and 69 died after
taking antihistamines since 1969. The real death toll can be much bigger
because the reporting of adverse reactions is not mandated.
The Consumer Healthcare Products
Association, an industrial trade organization that has defended the safety of
cough and cold medicines for pediatric use, also made it own 156-page safety
review and recommended that a warning label be printed to alert parents not to
use the products in children younger than 2.
But it has maintained that there is no harm to
kids between 2 and 6.
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."
The CDC confirmed that “three cases
of infant deaths in two states during 2005 that were determined by a medical
examiner or coroner to have been caused by cough and cold medications."
It is not more than speculation that
taking cough and cold medicines poses risk in young children.
Experts said at high doses, the
ingredient(s) in cold medicines can affect the heart’s electrical system,
leading to arrhythmias. Some medicines affect the blood vessels, potential
leading to hypertension and stroke. Children may get injured even at
recommended doses.
These cough and cold remedies are
not needed in the first place.
In 2006, the American College of
Chest Physicians also released clinical practice guidelines for management of
cough, advising health-care providers not to recommend cough suppressants and
other over-the-counter cough medications for young children because of
potential risks to children.
At the hearing held on Thursday, Dr.
Alejandro Necochea, representing Public Citizen called on the FDA to
immediately ban sales of all OTC cough and cold medicines for children under
the age of 12 years because children did not benefit from the drugs.
Physicians agreed that children who
are experiencing cough and or cold do not need any medicine for recovery
although in some cases use of such remedies provides some palliative effect.