Spurred by criticisms that cough and cold remedies don't work and may be dangerous for young children, drug manufacturers voluntarily removed 14 popular over-the-counter (OTC) medications marketed for children under age 2 in October. A week later, an FDA advisory panel recommended that such remedies not be given to children under age 6. The nonbinding recommendation, which applies to products containing decongestants, antihistamines, or antitussives, may lead to labeling changes, although this could take years.
A review of reports filed with the FDA between 1969 and 2006 found 54 deaths in children related to decongestants containing pseudoephedrine, phenylephrine, or ephedrine and 69 deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine, or chlorpheniramine.
The FDA panel recommended standardizing the sizes of dosing cups, droppers, and syringes packaged with OTC products to reduce the risk of overdose. It also called for more studies to determine whether the products actually work. Little research has been done to support the effectiveness of these products in children, and some products marketed for pediatric use have never been tested in children at all.
The American Academy of Pediatrics (AAP) and other groups support a ban on the use of OTC remedies in children under age 6. Noting that most colds are self-limiting, pediatric practitioners urge parents to focus on nondrug supportive care, such as positioning the child upright to facilitate breathing, maintaining hydration, and using steam or a salt-water nasal spray to clear mucus. For more information, visit the AAP Web site at http://www.aap.org and click on "Treating kids' colds without drugs."