Cough and cold medications that contain expectorants, antihistamines, nasal decongestants, and cough suppressants are commonly used to treat symptoms of upper respiratory infection in children younger than two years. However, in 2004 and 2005 an estimated 1,519 children younger than two years were treated in U.S. emergency departments for adverse events associated with use of cough and cold medications. Although the U.S. Food and Drug Administration (FDA) has approved the use of cough and cold medications for children two years and older, no FDA-approved dosing recommendations exist for children younger than two years. Therefore, the Centers for Disease Control and Prevention (CDC) has released a statement on the risks of cough and cold medications in children younger than two years. The statement appears in the January 12, 2007, issue of Morbidity and Mortality Weekly Report.

Evidence of the effectiveness of cough and cold medications in children younger than two years is limited. Systematic reviews of controlled trials involving these medications conclude that they are no more effective than placebo in reducing symptoms of upper respiratory tract infection. Additionally, cough suppressants containing codeine (Robitussin AC) and dextromethorphan (Delsym) have not been proven effective, and their use could lead to potential adverse events in children younger than two years.

Health care professionals should advise parents against administering cough and cold medications to children younger than two years because of the risk of toxicity and the lack of dosing recommendations. As an alternative to pseudoephedrine (Sudafed) and other nasal decongestants, physicians should recommend clearing the child's nasal congestion with a rubber suction bulb or using saline nose drops or a cool-mist humidifier to soften secretions.

Health care professionals also should be aware of the risks of serious illness or fatal overdose in children younger than two years who have been given cough and cold medications. To avoid overdose, physicians should prescribe these medications with extreme caution and should inquire about additional over-the-counter medications the child is being given. Additionally, physicians should be certain that parents understand the importance of administering these medications only as directed and are aware of the risk of an overdose if the child is given additional medications with the same ingredients.