Will debate pull the plug on $659M in pediatric OTCs?

11/12/2007

WASHINGTON —The most damning news to come out of last month’s Food and Drug Administration joint advisory panel meetings on children’s cough/cold remedies was that pediatric cough/cold medicines don’t work.

At least that’s the takeaway for many of the news reports published since. And that has the potential of scuttling sales of kids’ cough/cold medicines this season. For the 52 weeks ended Oct. 7 across food, drug and mass outlets (minus Wal-Mart), sales of all liquid cold medicines totaled $659.4 million, representing growth of 8.4 percent according to Information Resources Inc. Within that group of medicines, McNeil Consumer’s Children’s Tylenol was the No. 2 brand with $56.6 million in sales, up 431.8 percent, and Novartis’ Triaminic was the No. 5 brand with $36.2 million in sales, up 15.5 percent.

Parents buy kids’ cough/cold medicines. A lot of them. So what now?

In 2006, when the American College of Chest Physicians questioned the efficacy of kids cough formulations, sales of pediatric cough medicines dipped down and trips to pediatricians went up.

Will parents today have a similar reaction?

Hopefully, parents today will feel comfortable consulting their pharmacist or another health-care professional on alternative remedies or the practice of not administering any remedies, commented Winnie Landis, president of the American Pharmacists Association. But if these products are removed from the market in children’s doses, Landis expressed a concern that parents will cut doses of adult medicines and administer those doses to their children without consulting a healthcare professional.

Led by Joshua Sharfstein, commissioner of health in Baltimore, the petitioners called on the FDA to publicly state that OTC cough/cold products in children under the age of 6 were not found to be safe or effective given current clinical evidence. The petitioners also called for the FDA to mandate label changes prohibiting the use of cough/cold medicines in children under 6.

There are concerns, however, that many of the 11 studies put forth by the petitioners didn’t have a substantial study group, and one of the studies measured the efficacy of a cough medicine (dextromethorphan) eight hours after it had been given. Dextromethorphan is recommended for use every four hours. “I don’t understand how he can say that the product is ineffective,” Linda Suydam, president of the Consumer Healthcare Products Association, charged, “because he didn’t measure [results] in a time frame that was consistent with the way [the medicine] is labeled.”

Mary Tinetti, chairwoman of the FDA’s Nonprescription Drugs Advisory Committee, noted that the petitioners were relying on a small group of clinicals to support their position versus an extended history of pubic use. Tinetti said that one cannot disregard mass consumption of the products and suggested that the safety concerns are relatively small. “One can argue that there may be a wealth of evidence [supporting safety and efficacy of these products in children],” she said.

On the other side of the issue, CHPA acknowledged that the use of OTC cough/cold products in children under age 2 may be inappropriate, in part because of the difficulty to appropriately dose or administer an appropriate dose to infants. Many of the adverse events associated with use of cough/cold medicines in children can be directly linked to issues of overdosing, CHPA noted, suggesting that the issue may be addressed through public education as opposed to pulling products off shelves.

But cough/cold products are both safe and efficacious in children older than 2, CHPA contended, especially given the 95 million units each year that have been administered to children in the past 30 years. Parents wouldn’t re-purchase a product that didn’t have a measurable degree of symptom relief the first time, refuting that the medicines are not effective, and the associated adverse events compared with use in the general population is acceptably rare.

“How is the purchase of hundreds of millions of doses by parents explained?” asked George Goldstein, a non-voting industry representative on the FDA advisory committee. “I don’t believe the American parent or caregiver is—in a word—stupid.”

Still, the advisory committees voted almost unanimously that cold medicines should not be used in children under the age of 2 by a vote of 21 to one and voted 13 to nine in favor of not advising cold medicine use in children under age six. However, the committees leaned the other direction with regard to children between 6 and 12—seven committee members recommended that cold medicines not be used in this population and 15 members suggested that cough/cold medicine use in children of this age group was appropriate.

Several committee members expressed concern that there appears to be no evidence proving efficacy of cold medicines in children. Consequently, it would be irresponsible to recommend the use of these products given known serious adverse events, however rare those events might be. “The discussion I’ve heard regarding efficacy is that there is none demonstrated,” commented Robert Daum, professor of pediatrics at the University of Chicago Medical Center and member of the Pediatrics Advisory Committee. However, Tinetti reminded Daum that lack of evidence of efficacy does not necessarily mean lack of efficacy.

“I do not believe that these” products should be removed from the market, commented Amy Celento, a temporary voting member for this committee representing patients and families. “There are many, many adults who will … administer adult products to children” if products specifically marketed toward children are removed from the market.

But what’s not likely to happen is the mandated removal of all of these products marketed toward children under the age of 12, as was recommended by seven of the 22 panelists on the advisory committees; or even the removal of remedies marketed for use in children under the age of 6, which, by a split vote, the committee suggested should be done.

“I don’t think these products are going to be pulled,” Suydam said in an interview with Drug Store News following the meetings. “These products are very safe when used as directed. For children between the ages of 2 and 6, accidental ingestion is the leading cause behind misuse. That’s something that we can educate parents about easily.”

But it’s not just a pair of advisory committees that has been pressuring the FDA to do something about kids cough/cold medicines. Rep. Henry Waxman, DCalif., chair of the House Oversight and Government Reform Committee, called on CHPA to endorse the voluntarily removal of all cough/cold products marketed toward children under the age of 6 by its members almost immediately following the meeting.

Waxman commended CHPA’s voluntary withdraw of products marketed for use in children under 2, but expressed disappointment that CHPA is reportedly prepared to fight the advisory commit-tee’s recommendation on cough/cold products for children under 6.

Waxman has expressed a personal interest in the outcome of the original citizen’s petition—which calls for a ban on cough/cold products for children under the age of6. The lead petitioner is Waxman’s former senior aide—Sharfstein, who left Waxman’s office to assume the position of Baltimore’s commissioner of health.

Going forward CHPA has promised to execute on three initiatives—pharmacokinetic studies on children, which are studies that determine appropriate dosing for various age groups; CHPA-directed efficacy tests of monographed cough/cold medicines in children, if deemed necessary by FDA; and the initiation of an awareness campaign cautioning parents about the dangers of overdosing their kids.

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