FDA Is Against Use Of Oral, Over-The-Counter Cough, Cold Medicines In Children Under Two

Armen Hareyan's picture
Advertisement

Cough, Cold Medicines In Children

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 FDA decision against the use of oral OTC cough and cold medicines in children under the age of two.

Advertisement

The agency's recommendation reaffirms the October 2007 action by the leading makers of pediatric OTC medicines' to voluntarily withdraw "infant" oral cough and cold medicines for children under the age of two.

"Safety has always been and continues to be our top priority," said Linda A. Suydam, D.P.A, president of CHPA. "Last fall, the leading makers of OTC, oral cough and cold medicines for infants voluntarily withdrew these medicines out of concern that their potential misuse could lead to possible overdose among very young children. While CHPA and its member companies believe that the large majority of parents and caregivers know how to safely and appropriately administer these medicines, and that they are safe when taken as directed, we took this voluntary action recognizing that infants are especially vulnerable to accidental misuse."

"Today's decision by FDA reaffirms the correct course of action taken by the leading makers of these medicines last fall," Suydam added. "Since then, 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."

Advertisement