BELTSVILLE, Md. The City of Baltimore Health Department and the Consumer Healthcare Products Association locked horns again Thursday morning, over whether several monographed cough/cold medicines are appropriate for use in children under the age of six at a Food and Drug Administration public meeting held here.
The meeting is expected to result in a change in the cough-cold monographs, as it relates to use in pediatric populations, reported John Jenkins, director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research.
“This [public meeting is part of a] rulemaking process to get to a change in the monograph,” he told reporters during a lunch break in the day’s meetings. Outside of that rulemaking protocol, he said, parents should follow FDA recommendations issued in January that cough-cold products not be used in children under the age of two. “Beyond that parents should follow the directions on the labeling” as they are presented today, he said.
Jenkins noted that one of the concerns that the FDA will address as it debates appropriate use of cough-cold products in children is one of potential unintended consequences—will parents give OTC medicines indicated for use in adults to their children if children’s cough-cold medicines are removed from the market?
“Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,” commented Dr. Joshua Sharfstein, Baltimore’s health commissioner, according to an Associated Press report filed this morning. “There is nothing that is holding the FDA back from asking for a voluntary recall now of products marketed to kids under 6.”
Sharfstein challenged the assumption that parents would buck all healthcare professional recommendations, if the FDA were to advise these medicines not be used in children under age six. “The logic of this concern assumes parents will ignore safety warnings against use in children and give inappropriate products to their children,” Sharfstein testified. “As a pediatrician, I find this scenario unlikely, because in my experience, parents of all backgrounds listen to warnings and generally do what is right for their kids.”
CHPA, meanwhile, is asking the FDA for time to conduct pharmacokinetic studies on seven of those monographed OTC ingredients, develop and conduct efficacy studies on those ingredients and continue to raise public awareness that while there is significant value inherent in OTC medicines, they are still medicines and should be used according to label recommendations.
“Our science-based safety and efficacy program, already under way, is robust [and] well-defined,” Linda Suydam, CHPA president, testified before the FDA committee this morning. “Our foremost concern is the safety of children.”
According to CHPA, those seven PK studies, eight including the already-completed PK studies on pseudoephedrine, will help encourage appropriate use of cough-cold medicines in pediatric populations, thereby reducing the number of adverse events associated with misuse or overdosing with those products. According to Suydam, those eight ingredients represent approximately 95 percent of the OTC products for children on the market. CHPA’s consumer-awareness program is focused on safe use of OTC medicines, safe keeping of those medicines and the importance of reading and following product labels guidance.
In addition to its commitment to raise awareness around the appropriate use of OTC medicines in pediatric populations, Suydam announced that CHPA associate members last year agreed to discontinue using “doctor recommended” or “pediatrician recommended” in the promotion of pediatric cough-cold products.
Suydam reported that CHPA had partnered with the Nielsen Group in March to help track consumer retention of its awareness campaign on a periodic basis to help hone that message for greater retention.
One of the industry concerns include what parents might do if cough-cold medicines were advertised as not appropriate for use in children under age six. Phillip Walson, retired professor of pediatrics and pharmacology at the University of Cincinnati and CHPA advisor, cited studies suggesting 40 percent of parents would use alternative, perhaps more natural, cough-cold remedies, while 24 percent would extrapolate appropriate dosing from products labeled for adult use.