FDA Rejects Move to Ban the Sale of Cold and Cough Medicines for Young Children
October 3, 2008
FDA Rejects Move to Ban the Sale of Cold and Cough Medicines for Young Children

The FDA’s Center for Drug Evaluation and Research listened to public comment at a hearing on October 2, 2008 to assist in their drafting of recommendations for use of over-the-counter cough and cold medications for young children. The American Academy of Pediatrics argues that OTC products are ineffective in treating colds and coughs in children under 6 and called for a ban on the sale of these products. Thousands of children each year suffer health consequences from accidental overdoses and are treated in emergency rooms for symptoms ranging from excessive drowsiness to hives.  Officials stated that more research on the efficacy of cold and cough medications in older children is necessary before they will call for extending a ban on the sale of over the counter (OTC) cold and cough medications to children beyond 2 years of age. Federal officials worry that a ban on the OTC products may prompt parents to give young children adult medicine potentially causing a different problem. At the October 2nd meeting, officials did not give a timeline for publication on recommendations for use of OTC medications.

For more information on the public hearing please visit,
http://www.fda.gov/cder/meeting/cough_cold.htm