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Cold medicine for children under the age of six

Last week, safety experts urged the FDA to consider an outright ban on over-the-counter cough and cold medicines for children under the age of six.  Marketed under product names such as Toddler Dimetapp, Triaminic Infant and Little Colds, these medicines are reportedly of little effect in that age group, yet as many as 54 children have died in the past eight years after taking decongestants, and during the same period 69 children died after taking antihistamines.  The 300+ page report to the FDA points out that since these deaths are reported only on a voluntary basis, the actual death toll is probably significantly higher than the voluntary reports would suggest.

        An industry trade group that objects to the report from the FDA's scientists would limit the FDA to adding warning labels to pediatric cold medicines  advising against administering them to children under age two, in place of the current advisory to "consult a physician" before giving such medicines to infants:  despite this 150 page industry report--released on Friday, October 5, some companies such as Johnson & Johnson, continue to sell products labeled "infant" with labels depicting children under twenty-four months.

        The Centers for Disease Control and Prevention found that more than 1500 children under 24 months have suffered serious health problems associated with cold medicines in just the past three years.  In an article published on October 1, the New York Times reported that the Journal of the American Medical Association--one of medicine's most prestigious journals--demonstrated that more than one-third of all 3 year olds had received over-the-counter cough and cold medicines during a single 30 day period.    In 1990, American consumers spent almost $2 billion dollars on 30 separate brands marketed for kids--who suffer 6-10 colds per year, on average. 

        On Friday, the FDA also warned makers of 200 unapproved prescription medicines containing hydrocodone to discontinue sale of these medicines for use with children under age six.  There are reportedly a total of 800 pediatric cough and cold medicines on the market, despite consistent research findings suggesting that these products are not effective in children.  While it was once widely assumed that separate testing on childrens' bodies was unnecessary (and therefore has never been conducted), most scientists reject that assumption today.

Thompson O’Neil, P.C.
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