Should all children’s oral cough and cold medicines be withdrawn from the market?
No. These medicines are generally recognized as safe and effective by FDA, and have been relied upon for decades. Issues raised at FDA’s October 2007 advisory committee meeting are not about product safety. Adverse events associated with these trusted medicines are rare and are predominantly a result of misuse or unsupervised ingestion. Following consultations with the FDA, the nation’s medicine makers made voluntary updates to oral children’s cough and cold medicines. Because we recognize that FDA’s formal regulatory processes can take a long time to complete, the leading manufacturers of oral OTC pediatric cough and cold medicines, through ongoing discussions with FDA, are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines. Visit OTCsafety.org for more information.
