Infant cough-cold recall stings, rules for kids still pending

Drug Store News,  March 3, 2008  

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The Food and Drug Administration in January officially declared that use of any cough-cold products in children under the age of 2 was inappropriate. And while that announcement, which underscored the industry's voluntary recall of such products last fall (as announced by the Consumer Healthcare Products Association), may have had a chilling effect on sales of cough-cold products just as illness rates were picking up this year, it's the FDA's pending decision regarding the use of these products in kids under the age of 6 that's going to have a greater impact on the sale of cough-cold medicines.

For the 52 weeks ended Dec. 29, according to Nielsen Group data, sales of children's cold remedies were up 5.4 percent to $295.9 million across food, drug and mass (minus Wal-Mart), representing 8 percent of all cough-cold sales of $3.7 billion for the period.

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And while that data include the second-half of last year's cough and cold season, the fall withdrawal of the infant medicines has not been without its impact. "Beginning with our OTC segment ... our topline results were heavily influenced by the impact of two well-publicized external events; specifically the weak cough-cold season to date and the industry-wide voluntary withdrawal of pediatric cough-cold products negatively affected performance of our Chloraseptic and Little Remedies brands," said Mark Pettie, Prestige chairman and chief executive officer, last month in discussing the private-label company's third-quarter result. "To provide a sense of dimension to these effects, if we were to exclude the revenue of these two brands from both the current and prior year quarterly results, revenues for the balance of our OTC portfolio grew 14 percent versus a year ago," he said. With those brands results, Prestige's OTC portfolio declined by 1 percent to $45.1 million.

To date, there has been no compass that indicates in which direction the FDA will favor with regard to use of kids cough-cold medicines in children under the age of 6. The pair of FDA committees--including members from the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee--split on their vote on the issue in October, 13-9 in favor of not advising cold medicine use in children under the age of 6.

Several committee members who voted against the use of cold medicines in children under 6 expressed concern that there appears to be no evidence proving efficacy of cold medicines in children. On the other hand, the anecdotal evidence sways heavily in favor of efficacy. Research conducted for CHPA in January 2006 found that 96 percent of consumers reported cough medicines helped in providing some relief. As many as 89 percent of parents and caregivers observed that efficacy first hand in the relief of their child's cough symptoms and in making their children feel better.

There is also no firm timeline for the pending FDA decision. "Many of these drugs were monographed, as mentioned in the advisory committees, we'll have to go through a working group process," Charles Ganley, director of the FDA's Office of Nonprescription Products, told reporters in January, explaining why a decision of cough-cold use in other age groups was not at that time forthcoming.

The Centers for Disease Control and Prevention, in a recent report regarding emergency room visits resulting from misuse of cough-cold medicines (see sidebar), expressed concern that if cough-cold medicines for children younger than 6 were pulled off the market in an effort to reduce those adverse events, parents may be inclined to administer cough and cold medicines indicated for older children, or for adults, possibly increasing the number of serious adverse events. "Even after the recall of products for children aged 2 years, 64 percent of parents responding to a national survey still considered these medications very safe or somewhat safe, and 20 percent plan to continue to use OTC cough-cold medication for their children 2 years old," the report read. "Parents ... should not use products intended for older children to treat young children, and, as stated in the Food and Drug Administration's mandated label warning, parents should keep all cough and cold medications out of the reach of children," the CDC stated. "Parents and caregivers should throw away previously purchased products marketed to infants and toddlers ages 2 and younger."

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