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FDA Targets Cough Medicine For Kids Under Two

Agency acts on doctors' concerns about overdoses in children

By Mark Huffman
ConsumerAffairs.com

August 16, 2007

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Over-the-counter doesn’t mean just anyone should take it.

The U.S. Food and Drug Administration says many cough remedies sold without a doctor’s prescription should not be given to young children with a physician's approval.

The agency said it plans to assemble a panel of experts in October to review the use of some well known over-the-counter medications commonly given to children. The FDA says some may not be safe for children under age two.

The issue was first raised by physicians themselves. Several doctors submitted a petition to the FDA in March asking the agency to review the use of over the counter cough remedies given to young children. The petition cited reports of a number of overdoes and, in a few cases, deaths.

In the last few years, some health professionals have questioned the effectiveness of most over the counter cough medicines for anyone. The doubts were amplified in 2006 guidelines from the American College of Chest Physicians, which said cough expectorants or suppressants, including cough syrups and cough drops, do not treat the underlying cause of the cough.

Baltimore Health Commissioner Joshua M. Sharfstein, who signed the petition asking the FDA to review the use of cough medicine by young children, welcomed the new emphasis on the issue.

“The fact that they are doing this is illustrative that this is a real problem that is on their radar screen,” he told the Washington Post.

Sharfstein said there’s little evidence to suggest cold remedies help children under two, and significant concerns about their potential misuse.

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