FDA Warns Against Use of OTC Cough/Cold Products in Young Children

Yael Waknine

Disclosures

January 18, 2008

January 18, 2008 — Over-the-counter (OTC) cough and cold products should not be used to treat children younger than 2 years, the US Food and Drug Administration (FDA) warned parents and caregivers in a public health advisory issued yesterday.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," says Charles Ganley, MD, director of the FDA's Office of Nonprescription Products, in an FDA news release. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

OTC cough and cold preparations commonly include nasal decongestants, antihistamines, cough suppressants, and expectorants. These drugs can cause serious and potentially life-threatening adverse events in young children, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Death, convulsion, rapid heart rates, and decreased levels of consciousness have been reported.

In a previous communication issued in January 2007, the FDA and the Centers for Disease Control and Prevention estimated that during a 2-year period, 1519 children younger than 2 years were seen in emergency departments for evaluation after known or possible exposure to cough and cold products.

The current recommendation was based on the FDA's review of data and a discussion held during a joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees on October 18 and 19, 2007. The agency's review of data for children aged 2 to 11 years is ongoing, and further recommendations will be issued to the public as soon as it is completed.

In the interim, parents and caregivers who wish to use OTC cough and cold products for children aged 2 to 11 years are advised to

  • Carefully follow the directions on the product label and use only the measuring spoons or cups that are provided or specially made for its administration. Common household spoons should not be used because they come in different sizes and are not meant for measuring medicines.

  • Check the active ingredients included in each cough and cold product, particularly if more than 1 product is being used. Because active ingredients are often duplicated among preparations, combining them can increase the risk for overdose.

  • Select OTC cough and cold products with childproof safety caps when available, and keep them out of reach of children.

  • Understand that OTC cough and cold medicines do not treat the cause of the symptoms or shorten the duration of illness; they only relieve associated symptoms. These products should not be used to sedate a child or make them sleepy.

Additional information regarding these guidelines can be found online at http://www.fda.gov/consumer/updates/coughcold011708.html.

Adverse events related to use of OTC cough and cold products should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. 

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