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Medication Adverse Event Alert

January 15, 2007

ISSUE:Infant Deaths Associated with Cough and Cold Medications
MEDICATIONS:Medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants

The following was excerpted from an FDA Med Watch alert dated January 12, 2007:

"The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years. [January 12, 2007- MMWR Weekly - CDC]"

"This report … identified deaths of three infants aged <6 months in 2005, for which cough and cold medications were determined by medical examiners or coroners to be the underlying cause. The dosages at which cough and cold medications can cause illness or death in children aged <2 years are not known. Food and Drug Administration (FDA)-approved dosing recommendations for clinicians prescribing cough and cold medications do not exist for this age group. Because of the risks for toxicity, absence of dosing recommendations, and limited published evidence of effectiveness of these medications in children aged <2 years, parents and other caregivers should not administer cough and cold medications to children in this age group without first consulting health-care provider and should follow the provider's instructions precisely. Clinicians should use caution when prescribing cough and cold medications to children aged <2 years. Moreover, clinicians should always ask caregivers about their use of over-the-counter combination medications to avoid overdose in children from multiple medications that contain the same ingredient."

The report included a table of common ingredients contained in cough and cold medications for review (Table2):