FDA SAYS DON'T USE OVER THE COUNTER COUGH AND COLD MEDICINE IN CHILDREN LESS THAN TWO YEARS

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The U.S. Food and Drug Administration says that over-the-counter (OTC) cough and cold medicines should not be used to treat infants and children less than 2 years of age. OTC cough and cold medicines include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds. Expectorants bring up phlegm. Antitussives are supposed to quiet down coughing. Antihistamines are to dry secretions. Older antihistamines are associated with increased sleepiness. OTC cough and cold products include these ingredients: decongestants (for unclogging a stuffy nose), expectorants (for loosening mucus so that it can be coughed up), antihistamines (for sneezing and runny nose), and antitussives (for quieting coughs).



The terms on the label include "nasal decongestants", "cough suppressants", "expectorants" and "antihistamines". Cough and cold medicines OTC should not be used because serious and potentially life threatening side effects can occur from such use. "The FDA announcement does not include the FDA's final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing.



There are a wide variety of rare, serious adverse events reported with cough and cold products. "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".

FDA Recommendations On Use of Over-the-Counter Cough and Cold Products in Under 2 Year Olds