Statement from the Consumer Healthcare Products Association Regarding Materials Posted in Advance of Upcoming FDA Advisory Committee Meeting on Pediatric Over-the-Counter Cough and Cold Medicines

Washington, D.C. (September 28, 2007)—Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding materials posted online by the U.S. Food and Drug Administration (FDA) prior to the joint meeting of the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee scheduled for October 18 and 19. That meeting will address the safety and efficacy of over-the-counter (OTC) cough and cold medicines in children:

"The safe use of OTC cough and cold medicines in children is the number one priority of CHPA and its member companies who provide over-the-counter cough and cold medicines for pediatric use.

"CHPA and its member companies contributed scientific analysis and examination to FDA for public review regarding the safety and efficacy of OTC cough and cold medicines for children.

"Our analysis supports the safety of these important medicines when used in recommended doses. It also, however, illuminates rare cases of overdose. The makers of medicines have put forth the following recommendations to help reduce misuse.

    • Labeling - "We are recommending strengthening the labels on these medicines to help reduce misuse and confusion about using these medicines with children, particularly in those children under the age of two.
    • Education - "We are taking actions to address the misuse of these medicines as part of a multifaceted approach. We are launching a national education program to build awareness among parents and other caregivers about how to safely use over-the-counter medicines in children—and just as important, when not to use them. The campaign also will address the need for safekeeping of these medicines.
    • Research - "In addition, while years of practical application by both doctors and parents demonstrate the effectiveness of these ingredients in relieving symptoms of cough and cold, we are recommending that pharmacokinetic studies be conducted to affirm the current dosing in children aged two through under twelve.

"These initiatives are part of CHPA and its members’ long-standing commitment to providing the highest-quality medicines—the very medicines that millions of parents and families have trusted for decades to relieve symptoms of the common cold."

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

CHPA is the 126-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.