WASHINGTON Following an all-day public meeting Thursday held by the Food and Drug Administration regarding the appropriateness of marketing cough-cold products with scant pediatric data supporting safety and efficacy for children under the age of six, the Consumer Healthcare Products Association announced its progress in delivering safety and efficacy clinical trials for this category.
To date, CHPA has put together a comprehensive efficacy and safety program for children age two to under 12, including pharmacokinetic studies to confirm the dosing for the eight most commonly used OTC oral cough and cold ingredients. Once these dosing studies are finalized, CHPA plans to begin research on revalidating the effectiveness of these medicines.
In addition, CHPA stated it would continue to collect and review all available safety data around these medicines. “A comprehensive safety review in 2007 and data from the U.S. Centers for Disease Control and Prevention show that the majority of adverse events associated with OTC oral pediatric cough and cold medicines are a direct result of accidental ingestion,” noted Linda Suydam, CHPA president. “Reducing these preventable errors is the cornerstone of CHPA’s national educational program.”
CHPA will also continue its national education program that focuses on the root causes of adverse events and speaks directly to parents, day care providers, healthcare providers and other caregivers.
CHPA is partnering with a number of organizations in these efforts, including the American Pharmacists Association and the American Association of Family Physicians.