WASHINGTON Pharmacy retailers can expect parents to be even more confused about what to give their sick kids this year during cold and flu season. This is in the wake of an FDA hearing Oct. 2 on the appropriate use of pediatric OTC cough-cold remedies, followed closely by a move among makers of these medicines to issue new package labels to alert parents that the products are not for use in children under four years old.Run the numbers and it leaves one huge hole in the market. According to 2007 U.S. Census Bureau estimates, there are 20.7 million children under age six. It is expected this group will suffer, on average, three to eight colds this year. That adds up to anywhere from 62.1 million to 165.6 million opportunities for pharmacy retailers to either help mom find an alternative remedy—e.g., supplements, humidifiers, topical menthol rubs—or let junior’s symptoms go untreated.
The Consumer Healthcare Products Association earlier this month announced that its members have initiated a voluntarily label change to advise parents that use of the medicines is not advisable in children under the age of 4. As this issue of Drug Store News went to press, many products featuring the new labels already had begun to ship to retailers.
Important to keep in mind, makers of these products insist, it is not the safety of these products themselves but how people use them that is really at the heart of the labeling changes. “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,” explained 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.”
In addition, CHPA manufacturers are voluntarily adding new language that warns parents not to use antihistamines to sedate or make their child sleepy, and the organization also has expanded its national program to educate parents, caregivers, and healthcare professionals on the appropriate dosing and use of OTC medicines in children.
These moves came on the heels of the FDA’s January announcement banning kids OTC remedies for children under 2 years old. Apparently that information remains top of mind for many consumers.
According to a June 2008 Survey.com poll of 606 parents conducted, 64 percent of all parents, including parents of children between the ages of five and 12, have made up their minds not to treat their children’s cold symptoms with traditional allopathic remedies. As many as 70 percent of parents with children under the age of 4 reported they had given their children cold medicine when they were sick in the past. That suggests that millions of parents will be looking for other options this cold and flu season.
That survey notwithstanding, one key concern shared both by OTC industry leaders and the Food and Drug Administration officials is what parents might do as a result. One the plus side, Phillip Walson, retired professor of pediatrics and pharmacology at the University of Cincinnati, and an advisor to CHPA, cited studies suggesting that 40 percent of parents would seek an alternative, perhaps all natural, cough-cold remedy; on the alarming note, however, another 24 percent would attempt to calculate appropriate dosing for their kids from products labeled for adult use—in other words, take their best guess.
“We’re very concerned in seeing a shift of people using adult products [for their children],” commented John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research, during the FDA’s Oct. 2 public meeting on the appropriate use of OTC pediatric cough/cold formulations.
Meanwhile, CHPA continues to back pediatric pharmacokinetic and efficacy studies on the seven most common monographed cough-cold ingredients. Together with pseudoephedrine, which already is backed by PK studies, those eight ingredients represent approximately 95 percent of the OTC products for children on the market, Suydam said.
Following the Oct. 2 meeting, FDA officials promised to take action—though exactly what action had yet to be determined, according to Jenkins. “This [public meeting is part of a] rulemaking process to get to a change in the monograph,” he said. Those closest to the situation have told Drug Store News it is unlikely that any action could occur any time before later in 2010 at the earliest, as any proposed change to the respective monographs would be followed by a comment period before any finalized rule change could be issued.
By that time, CHPA-conducted PK and efficacy studies could very well be complete, providing proof of the safety and efficacy of these medicines in a clinical setting versus the 30-plus years of anecdotal safety and efficacy experience that parents have relied upon in the past. And that could rewrite the rules for pediatric OTCs one more time before today’s kids are ready for their big-boy pants.