Resources for Food and Drug Administration (FDA)

FDA To Consider New Rules for Children’s Cold Medicines

www.newsinferno.com

The rules regulating over-the-counter children’s cold medicines are about to be revised by the Food & Drug Administration (FDA), the agency announced late last week. Concern has been growing over the past several years that over-the-counter cold medicines meant for child are ineffective and unsafe, and many patient advocates hope the impending rule changes could ultimately lead to the drugs being removed from the market.

Earlier this year, the FDA issued a warning advising that over-the-counter cold and cough medicines should not be given to children under two. The warning came after a 2007 study conducted by the Centers for Disease Control found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common over-the-counter decongestants and antihistamines. A second study by FDA safety reviewers reached similar conclusions. Their research found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines.

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