CHPA advises parents not to give cough-cold remedies to infants, toddlers
WOONSOCKET, R.I. The Consumer Healthcare Products Association on Tuesday announced that the industry will voluntarily advise parents not to administer cough-cold medicines to children under the age of four. CHPA members last year voluntarily removed from the market any medicines marketed or merchandised to infants under the age of two; the under-four label change will be sold-through this cough-cold season, however.
CVS/pharmacy released a statement Tuesday morning supporting the label changes. “The health and safety of our customers is our highest priority and we support CHPA’s voluntary action,” stated Michael Bloom, senior vice president of merchandising at CVS/pharmacy. “As pediatric cough and cold medicines have been declared safe and effective by the FDA, it is also important that our customers have access to these products during cough and cold season while our suppliers transition to labels with new pediatric dosing directions.”
CVS/pharmacy is working with its suppliers to ensure that the OTC medicines will be available in its stores with new pediatric dosing directions as quickly as possible, the pharmacy operator stated. In the meantime, CVS will continue to keep the current versions of the 130 products it offers available for customers who rely on these medicines to treat their families’ cold and allergy symptoms.
“Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children,” stated Linda Suydam, president of CHPA. “As a result, the leading manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.”
CHPA consulted with FDA in the aftermath of last week’s public meeting regarding whether or not several monographed cough/cold medicines were appropriate for use in children under the age of six. After that meeting, the FDA promised action, however acknowledged that that action, in the form of rulemaking, could take several months before a proposed rule change to the governing monographs would be introduced.
In addition to the marketing ban on children under the age of four, CHPA manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy.
Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral OTC pediatric cough and cold medicines with the new labels and packaging. “As with other OTC labeling changes in the past, FDA has indicated it does not believe this labeling change warrants the removal of products with the existing labeling from store shelves during this time of transition,” Suydam said.
CHPA has also expanded its national education program aimed at parents, caregivers, and healthcare professionals on appropriate dosing and use of OTC medicines in children.