Safety and Efficacy in Pediatric Cold Medicines

Child Medication Safety

Following is a statement by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association (CHPA), regarding the safety and efficacy of over-the-counter pediatric cough and cold medicines:

"Millions of Americans safely and effectively use over-the counter cough and cold medicines every year - both for themselves and for their families. These medicines have been found safe and effective by the U.S. Food and Drug Administration (FDA) and are the same medicines that families have safely relied upon for decades to help relieve cough and cold symptoms and make their children feel better.

"OTC cough and cold remedies have a long history of safety when used according to the label. The most important information for all consumers is that OTC medicines are real medicines and must be used according to the label instructions at all times. In addition, it is worth noting that the labels of all cough and cold medicines for children direct parents and caregivers to contact a physician before giving to a child under two (at a minimum).

"Current FDA assessment of the safety and efficacy of approved children's over-the-counter antitussives, expectorants, nasal decongestants, antihistamines, and combination cough cold products is based on scientific studies in children and/or on extrapolation from extensive data in adults. This process of extrapolation follows internationally recognized recommendations for diseases which are similar in adult and pediatric patients and applies to the symptoms and conditions for these medicines.

"The makers of medicines welcome the opportunity to continue working with FDA to ensure consumers have access to the safe and effective medicines they rely on."

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