Children Cough Medicines Subject To Review

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.
A week before the FDA convened a panel of experts to consider the petition in October 2007, drug manufacturers voluntarily pulled all over-the-counter cough and cold products for children younger than 2.
The panel concluded that there was little evidence the remedies worked for children younger than 12, recommended that they not be used at all in those younger than 6, and called for new research to establish their safety and effectiveness directly in children.
In January, the FDA issued a public health advisory formally warning against using the products on children younger than 2, but it said the agency was still considering what to do about older children.