FDA schedules hearing on children's cold meds

NEWS IN BRIEF — Posted Sept. 15, 2008

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The Food and Drug Administration is proceeding with efforts to revise the labels on children's over-the-counter cough and cold medications that include decongestants, expectorants, antihistamines and antitussives.

The agency has scheduled a public hearing on the matter Oct. 2 in Beltsville, Md., where it intends to gather information on the types of studies needed to assess the safety and efficacy of the drugs and whether the medications should continue to be sold OTC or if prescriptions should be required.

In January the FDA issued a public health advisory recommending the drugs not be used to treat infants and children younger than 2 because of serious and potentially life-threatening side effects. The agency's advisory committee had recommended the medications not be used in children younger than 6.

The issue was first raised in a petition sent to the FDA last year by a group of Baltimore physicians.

Note: This item originally appeared at

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