FDA Panel Recommends Ban on Cold Medicines for Young Children
An FDA advisory panel on Friday voted 13-9 to recommend that the agency ban the sale of over-the-counter cough and cold medicines for children younger than age six, the New York Times reports.
Members voted 21-1 that the products should be banned for children younger than age two (Harris, New York Times, 10/20). The panel by a 15-7 vote decided against a similar recommendation on use of the drugs for children ages six to 11, according to the Washington Post. The decisions also include antihistamines for treatment of allergies.
FDA is not required to act on the recommendations, but agency officials said they would review the panel's work and formulate the necessary steps to address the issues raised (Stein, Washington Post, 10/20).
The panel found no evidence that the treatments are effective in young children, but some of the members voted against an outright ban because there are no other options for children with minor ailments (New York Times, 10/20). Several cough and cold medicine makers -- including Johnson & Johnson, Novartis and Wyeth -- recently decided to withdraw versions of the drugs for children younger than two, but the panel's recommendations go "well beyond their action," the Wall Street Journal reports.
FDA said that only 11 studies have been conducted on the products and children in the past five decades and that most showed the drugs to be ineffective, although agency staffers also said that many of the studies had design flaws. The panel said that more clinical studies should be conducted for use of the drugs in children age 11 and younger (Corbett Dooren/Wilde Mathews, Wall Street Journal, 10/20).
The panel also recommended that the labeling on the medications be changed from "Consult a Physician" for children younger than age six to "Do Not Use," the Baltimore Sun reports. In addition, the panel said that "Pediatrician Recommended" and similar phrases should be omitted from packaging (Emery, Baltimore Sun, 10/20).
The Consumer Healthcare Products Association defended the use of the medications in older children when taken at appropriate doses.
CHPA President Linda Suydam said that she expects that the products to remain on the market and that they are safe for children two years old to six years old. FDA officials said that any changes to labeling would undergo a lengthy federal rulemaking process (Wall Street Journal, 10/20).
FDA between 1969 and 2006 received 54 reports of children's deaths linked to decongestants and 69 reports linked to antihistamines, according to a letter from Rep. Henry Waxman (D-Calif.) to CHPA (Yager, Los Angeles Times, 10/20).
In another examination on Friday, the panel looked at medicines that combine multiple ingredients and use difficult methods of delivering the drugs that could lead to overdosing. Some at FDA recommend banning combination products and mandating standardized, accurate dosing devices (Bridges, AP/Seattle Times, 10/19).
Three broadcast programs recently reported on the panel's recommendations. Summaries appear below.
- ABC's "World News": The segment includes comments from panel member Robert Daum of the University of Chicago; Daniel Levy of the American Academy of Pediatrics; Suydam; and a parent (Stark, "World News," ABC, 10/19). Video of the segment and expanded ABC News coverage is available online.
- KPCC's "Patt Morrison": The segment includes a discussion with Richard Pan, a pediatrician and professor of pediatrics at UC-Davis Medical Center, about the recommendations (Morrison, "Patt Morrison," KPCC, 10/19). Audio of the segment is available online.
- NBC's "Nightly News": The segment includes comments from Daum; parent representative Amy Celento-Stamateris; panel member Ruth Parker of Emory University; and Suydam (Bazell, "Nightly News," NBC, 10/19). Video of the segment is available online.
- NPR's "All Things Considered": The segment includes a discussion with NPR correspondent Allison Aubrey about the recommendations (Norris, "All Things Considered," NPR, 10/19). Audio of the segment is available online.