Published Online: Saturday, December 1, 2007

Responding to concerns raised by the nation's pharmacists, an FDA nonprescription drug advisory committee called for new restrictions on the use of OTC cough and cold medicines by children aged 6 and under.

The group's recommendation came on the heels of testimony by the American Pharmacists Association (APhA) which called on the FDA to require more complete, comprehensive, and understandable labeling information on OTCs intended for pediatric patients.

"Pharmacists rely on the FDA to determine whether medications, including OTC products, are safe and effective," community pharmacist Winnie Landis said on behalf of APhA."However, the number of products from which consumers must choose combined with confusing labeling can lead to unintentional misuse of these products."

Landis advised parents trying to treat their children for coughs and colds to "take advantage of their pharmacist's medication expertise."

The APhA witness also recommended a series of additional steps to promote the safer use of pediatric medicines, including requiring standardized dosage units, improved OTC drug monograph information, and a ban on the "use of same brand name or brand name line extensions when the products contain different active ingredients."

Additionally, Landis called for new OTC drug labeling instructing patients to: "Ask your doctor or pharmacist about the directions for using this product."

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