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FDA Warns Against Use of Cough Medicines in Children Younger Than 2 Years

Cold and cough medicines are not innocuous, particularly if they are used inappropriately.

On August 15, 2007, the FDA issued a public health advisory regarding the use of nonprescription cough and cold medicines in children. In 2004 and 2005, more than 1500 children younger than 2 years who took cough medicine were treated for adverse effects, such as stroke and hypertension.

The details of the warning are as follows:

• Parents should not use cough and cold products in children younger than 2 years unless they are given specific directions by a healthcare provider.
  
• Parents should give only medicine that include directions for children and should administer only the specified amount and number of times each day.
  
• Parents should inform a healthcare provider about any other prescription or over-the-counter medicines they are giving to their children.
  
• Parents should use only a dropper, dosing cup, or dosing spoon for measuring (a kitchen teaspoon or tablespoon is not appropriate for measurement).
  

Comment: Cold and cough medicines are not innocuous — particularly if the drug is used inappropriately by parents. In addition, data are limited about these medicines’ effectiveness for the treatment of cold symptoms. I always tell parents: If I could cure the common cold, I would be a very rich man. My general advice to parents is: Give fluids and control fever, but don’t give cough and cold medicines.

— Howard Bauchner, MD

Published in Journal Watch Pediatrics and Adolescent Medicine September 12, 2007

Citation(s):

U.S. Food and Drug Administration (FDA). Public Health Advisory: Nonprescription cough and cold medicine use in children. 2007 Aug 15 . (http://www.fda.gov/cder/drug/advisory/cough_cold.htm)

Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications — United States, 2005. MMWR Morb Mortal Wkly Rep 2007 Jan 12; 56:1-4. (http://www.cdc.gov/od/oc/media/mmwrnews/2007/n070111.htm)

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