Children & Women OTC cough/cold medicine may do more harm than good
By Ben Wasserman
Oct 3, 2008 - 1:48:27 PM
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Friday
October 3, 2008 (foodconsumer.org) – Yesterday, experts and consumer safety
advocates at a hearing asked the Food and Drug Administration to ban over-the-counter
cough and cold medicines for use in children under the age of 6 years or make
them prescription drugs.
They
said evidence is lacking to suggest that taking such OTC medicines help
children who suffer coughing and colds for which pediatricians often advise parents
not to use any medicine in the pediatric patients at all.
Safety
advocates also said evidence is abundant to suggest that these drugs can do
more harm than good.
A
study published in the Mar-April 2008 issue of Pediatr Nurs says “ during a
2-year period from 2004 and 2005, emergency departments treated over 1,500
children under the age of 2 years for adverse events related to
over-the-counter (OTC) cough and cold medication use; these incidents include 3
infant deaths.”
Physicians
groups have repeatedly asked the FDA to regulate the OTC cough and cold
medicine based on the same reasons presented to the agency on Thursday.
Last
year, the FDA posted a health advisory regarding use of OTC cough and cold
remedies to warn parents not to give their kids the OTC drugs after a panel of
experts commissioned by the agency recommended a ban on use of the medicines in
children under 6.
But the FDA did not
take any action to ban anything.
This
time, health officials at the FDA said the agency is concerned
that a swift ban, which is supported by pediatricians' groups, could prompt
parents to give adult medicines to their children.
The nearly $1 billion-sales-a-year industry volunteered last
year to put a warning for OTC cough and cold medicines for use in children
under 2 years.
But it says there is no
need to ban their use in children between 2 and 6 years.
The FDA said before it can take any action, it needs more
data on safety and efficacy of the OTC cough and cold medicine which can be
found nowhere because these drugs have not been subject to rigid trials.