Thursday, January 17, 2008

FDA bans cold meds for kids under 2, considers ban for under age 12

The U.S. Food and Drug Administration on Thursday issued a Public Health Advisory recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use, according to an FDA press release. These include death, convulsions, rapid heart rates, and decreased levels of consciousness.

"These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. According to an Associated Press story on the move, "the Centers for Disease Control and Prevention last year reported that more than 1,500 babies and toddlers wound up in emergency rooms over a two-year period because of the drugs."

In October, the FDA's advisory board voted that the drugs were not effective and shouldn't be used in kids under age 6, according to the AP story. According to the FDA press release, the agency is continuing to review data regarding the use of OTC cold medicines in all children under age 12 prior to issuing a formal recommendation.

More from the press release:
Pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:
  • Follow the dosing directions on the label of any OTC medication,
  • Understand that these drugs will NOT cure or shorten the duration of the common cold,
  • Check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and
  • Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

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