In a press release issued today, the FDA has declared that over the counter cough and cold drugs are not safe or effective for children below 2 years of age.  The types of cough and cold remedies the release applies to include over the counter decongestants, expectorants, antihistamines, and cough suppressants.  The following is a quote from the release:

 “The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2,” said Charles Ganley, M.D., director of the FDA’s Office of Nonprescription Products. “These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2.” 

In addition, the FDA has an ongoing study into the use of these OTC remedies on children in the 2 to 11 year old range.  No recommendations have been made thus far, but the FDA plans to issue a report when the study is complete.  The following is a list of recommendations in regarding to this age group: 

  • Follow the dosing directions on the label of any OTC medication,
  • Understand that these drugs will NOT cure or shorten the duration of the common cold,
  • Check the “Drug Facts” label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and
  • Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

This page is the official Public Health Advisory issued by the FDA on the topic.  And this page contains CNN’s coverage of the story.

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