No over-the-counter (OTC) cough and cold products should be used to treat children and infants younger than 2 years old, according to a press release from the Food and Drug Administration (FDA) on Thursday.

 Using these types of medication can have serious and potentially life-threatening results.  Those medications warned against using in the release are decongestants, expectorants, antihistamines and cough suppressants.

 Side effects reported with cough and cold products, though rare, are quite serious and include rapid heat rates, convulsions, decreased levels of consciousness and death.

 “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, MD, 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.”

 Currently the FDA does not have a final recommendation for use of OTC cough and cold medicines for children in the 2-11 age groups.

 “The FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. The agency plans to issue its recommendations on use of the products in children ages 2 to 11 years to the public as soon as the review is complete.”

 Thursday’s news was based on the FDA’s data review and discussion at the Nonprescription Drugs and Pediatric Advisory Committees meeting in October 2007.  Details of those meetings can be found at the FDA website here.

 The news is not new.  In January 2007 the CDC posted a release about cold medicine usage in small children and infants on their website:

 Cough and cold medicines can be harmful and should be used with caution in children under 2 years of age. Although it is very rare, we identified three infants who died from the toxic effects of cough and cold medicines in 2005.

In addition, in 2004 and 2005, over 1,500 children less than 2 years old were treated in U.S. emergency rooms for adverse events from cough and cold medicines. While these drugs are effective in older children and adults, there is little evidence these drugs help in children under 2 years old. Parents should always consult a healthcare provider before giving cough or cold medicine to kids under 2 years old.

Healthcare providers should use caution when giving cough and cold medicines to children under 2 years old.
Below are the recommendations from the FDA:

Pending completion of the FDA’s ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:

  • 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