The Food and Drug Administration has announced plans to revise standards for over-the-counter cough and cold medications for children. The FDA said it will change the criteria that have allowed the products to remain on drugstore shelves . This could result in removal of the products from the market.
The FDA action is in response to increasing concerns that the remedies are ineffective and could be unsafe. Specifically, the action is in response to a petition filed in March 2007 by a group of pediatricians asking the FDA to restrict the use of the products, citing a lack of evidence that they work and mounting evidence they can cause hallucinations, seizures, trouble breathing, heart problems and other complications, including occasionally deaths.
The petition pointed out that the remedies had been allowed to stay on the market because they were approved at time when it was not considered appropriate to test medications directly in children. Instead, studies in adults were extrapolated to children, a practice now considered inadequate, the petition said.
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