What action has FDA taken to date regarding oral pediatric cough and cold medications?
On October 18 and 19, 2007, an FDA advisory committee discussed the safety and efficacy of OTC cough and cold medicines for children. Adult cough and cold medicines were not part of this examination. The panel, in a split vote of 13-9, voted to recommend to FDA that oral OTC cough and cold active ingredients should no longer be available for use in children under six years of age. This recommendation was limited to symptoms of the common cold and did not include, for example, expectorants for cough or antihistamines for allergy. On January 17, 2008, FDA issued a public health advisory instructing parents not to use oral pediatric cough and cold medicines in children under the age of two. The agency also concurred with the industry’s request to add label language telling parents not to use these products to sedate children. On October 2, 2008, FDA held a public meeting to gather more information on the regulatory process for pediatric cough and cold medicines and on the issue of scienti
