Cough and Cold Medications Update - Infant Deaths and Use in Children
October 10, 2008
The FDA recently notified the public about the Consumer Healthcare Products Association’s (CHPA) decision to modify the product labels of all over-the-counter (OTC) cough and cold products. The product labels will now state "do not use" in children less than 4 years of age. Also, new child-resistant packaging and measuring devices will be included with the OTC products. These actions are intended to prevent misuse of OTC cough and cold products in children.
In January 2008, the FDA completed its review of safety information on the use of OTC cough and cold products in children less than 2 years of age. The FDA is not recommending the use of these OTC cough and cold products in children under the age of 2 years due to serious and possibly life-threatening side effects including convulsions, decreased consciousness, tachycardia, and death. Cough and cold products may include a combination of ingredients containing antihistamines, nasal decongestants, expectorants, and antitussives. Efficacy has not been demonstrated with these products in children less than 2 years of age.
In January 2007, the FDA issued an alert regarding the Morbidity and Mortality Weekly Report (MMWR) article published by the Centers for Disease Control and Prevention (CDC) describing deaths in infants less than 12 months of age that were associated with cough and cold medication use. These medications were the underlying cause of death in 3 infants < 6 months of age in the United States. All 3 infants had high pseudoephedrine blood concentrations and none had cardiac abnormalities. In October 2007, the FDA’s Nonprescription Drugs Advisory Committee made a recommendation to not use OTC cough and cold products in children under the age of 2. The FDA published a Public Health Advisory providing recommendations regarding the use of cough and cold products in children.
The FDA is still reviewing the safety and efficacy of OTC cough and cold products in children and will revise its OTC list of approved products and amounts of approved ingredients as necessary. Products labeled with the January 2008 warning (do not use in children under 2) will not be removed from retail stores. New products must be labeled with the October 2008 warning (do not use in children under 4). For a short period, retail stores may carry products with both warning labels. Care givers should follow the label warnings and contact their healthcare provider with questions or concerns. Additional Information is available at the following links:
- FDA MedWatch Alert – October 2008:
- FDA News Release – October 2008:
- Public Health Advisory - Nonprescription Cough and Cold Medicine Use in Children:
- Questions and Answers for Consumers:
- FDA MedWatch Alert – August 2007:
- FDA MedWatch Alert – January 2007:
- MMWR Weekly Report
October 10, 2008; January 22, 2008; August 20, 2007; January 19, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.