FDA Warns Parents Against Inadvertent Overdosing Children with Non-prescription Medications

News 01/21/1992 FDA Warns Parents Against Inadvertent Overdosing Children with Non-prescription Medications
P92-2                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Faye Peterson - (301) 827-6242

    The Food and Drug Administration today warned parents against             
inadvertent overdosing of children with liquid nonprescription medications    
for colds and flu.
    Dose cups often cap the bottles of these medications, providing a         
convenient measure, but FDA cited instances in which parents either misread   
the dose cup markings or misread the directions, providing children with      
several times the recommended dosage.
    Even seemingly small doses of the common painkiller acetaminophen -- if   
over the recommended amount -- can be dangerous, if given over a period of    
several days, FDA said.
    "If the label says to give two teaspoons every four hours, that's the     
amount the child should get at the prescribed intervals," said FDA            
Commissioner David A. Kessler, M.D.  He also urged parents to read            
ingredient labels carefully, so they don't provide the same ingredient in     
two medications.
    "If the condition worsens or fails to improve, the child should be seen   
by a physician," Dr. Kessler said.  "If parents have any questions about the  
proper dose of a medication, they should consult their pharmacist or          
physician."
    The FDA said these precautions are particularly pertinent now when        
influenza is being reported nationwide in epidemic proportions.
    The potential problem of accidentally overdosing children with            
acetaminophen came to light when FDA received a report of a child who had     
inadvertently been given three times the intended dose.  The child's          
parents, using a "dose cup" packaged with the drug, measured to the "two      
tablespoon" level marked on the cup, instead of giving the "two teaspoon"     
dose that was recommended in the drug's labeling.  There was no "two          
teaspoon" measurement on the cup.  
    In FDA's follow-up of this incident, additional reports of dosing errors  
involving medicine cups began to surface.  As a result, FDA began a survey    
of OTC liquid medication makers to ensure that the labeling of all these      
products is compatible with their dose cups and that the cups are easily      
readable.
    In cooperation with FDA, the Nonprescription Drug Manufacturers           
Association and the Private Label Manufacturers Association (trade            
organizations representing OTC drug manufacturers) have asked member and      
non-member companies to review OTC liquid products packaged with dispensing   
or dose cups and to take appropriate action based on FDA concerns.  
    Though no serious injuries have been reported involving dose cups, two    
manufacturers have undertaken voluntary recalls of products packaged with     
dose cups found to be incompatible with labeling instructions or of poor      
quality.
    The FDA is one of the eight Public Health Service agencies within HHS.
                                    ###