Warning on Using Cough and Cold Medicines in Young Children
FDA Patient Safety News: Show #62, April 2007

The CDC recently warned about the potential hazards of administering cough and cold medications to children and infants under two years old. The article cites over 1500 cases in which children under two were treated in emergency departments for adverse events associated with these drugs. It also described 3 cases where infants died as a result of these medicines.

The instructions on OTC cough and cold medications advise consumers to "consult a doctor" for children under the age of two. But clinical trials that would establish dosing guidelines for this age group do not exist. The article also cites clinical trials indicating that these medicines are no more effective than placebo in reducing coughs and other upper respiratory symptoms in this age group.

Because of the risks of toxicity, lack of scientifically established doses for young children, and limited evidence of effectiveness, the CDC says clinicians should use caution when prescribing cough and cold medications to children under two. In addition, clinicians should always ask caregivers about their use of OTC combination medications, in order to avoid overdose from multiple medications that contain the same ingredient.

Parents and other caregivers should only administer cough and cold medications to children in this age group when following the exact advice of their doctor. Clinicians should be certain that caregivers understand both the importance of administering these medications only as directed and the risk of overdose if they administer additional medications that might contain the same ingredient.

Additional Information:

FDA MedWatch Safety Alert. Cough and Cold Medications in Children Less Than Two Years of Age. January 12, 2007.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152111.htm