FDA warns against OTC cold meds for kids younger than 2

Review continues on the safety and effectiveness of cough and cold remedies in children ages 2-11.

By Stephanie Stapleton — Posted Feb. 4, 2008

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A Food and Drug Administration Public Health Advisory was issued Jan. 17 warning that over-the-counter cough and cold products should not be used to treat infants and very young children because very serious side effects can occur, including death, convulsions, rapid heart rates and decreased levels of consciousness.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, MD, director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective [for this age group]."

The statement was based on a review of data and the discussions held at an October 2007 joint meeting of the Nonprescription Drugs and Pediatric Advisory committees. The agency is reviewing data regarding use of these medicines in children ages 2 to 11. It will communicate additional recommendations in the near future.

"It's critically important for parents to receive clear information about the risks and lack of benefit from these drugs," said American Academy of Pediatrics President Renee Jenkins, MD, in a statement. The AAP supported the FDA's Jan. 17 action as an important first step. "We urge FDA to continue its analysis of the existing data on these medicines intended for children over age 2 and take appropriate action, including initiation of immediate, rigorous scientific studies as needed to determine the drugs' safety and efficacy."

In the meantime, the agency urges those who choose to use these products for the 2-11 age group to follow the dosing directions on the OTC medication's label; check the "drug facts" label to learn what active ingredients are contained in the products because many contain multiple ones; and use only measuring spoons or cups that are packaged with the medicine or made especially for measuring drugs.

Suggestions on ways to soothe kids with coughs and colds are available on the AAP's Web site (link).

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External links

The Food and Drug Administration's public health advisory on the use of nonprescription cough and cold medicine for children (link)

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