FDA Bulletin on Kids' Oral, Over-the-Counter Cough and Cold Reaffirms Industry's October 2007 Voluntary Withdrawal

Agency announcement reinforces need for increased communication with consumers

Washington, D.C. (January 17, 2008)–On behalf of the leading makers of over-the-counter (OTC) cough and cold medicines, the Consumer Healthcare Products Association (CHPA) offered its support for today’s U.S. Food and Drug Administration (FDA) decision against the use of oral OTC cough and cold medicines in children under the age of two. The agency’s recommendation—which follows industry’s voluntary withdrawal of these medicines last fall—hopes to reach those consumers who may not be aware of the possible risks, particularly those risks related to misuse, associated with administering these medicines to children under two.

"Today’s announcement from FDA underscores the need for parents and caregivers to always follow label directions closely. Last fall, the leading makers of OTC, oral cough and cold medicines for infants voluntarily withdrew these medicines for children under two out of concern that their potential misuse could lead to possible overdose among very young children," said Linda A. Suydam, D.P.A, president of CHPA. "CHPA and our member companies stand behind the safety and efficacy of these medicines when used as directed in children over two years. While we know that a majority of parents and caregivers know how to safely and appropriately administer these medicines, it is our top priority to educate all parents and caregivers on how to correctly use OTC medicines."

Recent data presented to the FDA advisory committee showed that oral OTC cough and cold medicines are very safe when used as directed in children over two years, and that, while very rare, serious adverse events are generally the result of overdose from accidental ingestion or misuse. This data underscores the importance of educating all consumers on the importance of always following the directions, using the correct dosing device, keeping medicines safe, and consulting their doctor with any questions. Last fall CHPA began its education campaign to promote the safe use of OTC medicines in children and will soon launch new initiatives to underscore the importance of safe use and storage of all medicines.

Suydam added: "Since the fall, we have been working with the retail community, healthcare professionals, and FDA officials to ensure that parents have the tools they need to safely and appropriately administer OTC oral cough and cold medicines to children over the age of two. We have already begun a new educational campaign for parents and caregivers of small children, and remain intent on ensuring that parents have access to the very best OTCs for their families, as well as accurate information about safe and appropriate OTC cough and cold medicine use in children."

Helpful tips for parents and caregivers can be found at http://www.OTCsafety.org/Parents.

NOTE TO EDITORS: A list of the infant oral cough and cold medicines withdrawn from the market voluntarily is available here.

Contact: Elizabeth Funderburk, 202.429.9260 (w) 202.256.5677 (m)


CHPA is the 127-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.