FDA: No under-six cough-and-cold meds

November 1, 2007

Two committees move closer to banning untested OTC meds for young children.

Food and Drug Administration (FDA) advisory committees voted that cough and cold over-the-counter medications should not be used in children under 6. They also produced several hours of recommendations and opinion on pediatric medication safety and efficacy, which the agency has vowed to consider carefully.

On October 19, in Washington, DC, the panels voted 13-9 that cough and cold over-the-counter medications should not be used for children between 2 and 6 years of age. The statement said there are not adequate studies to prove effectiveness in children that age. It did not say that the products are not effective.

The committees also voted 21-1 that the products should not be used in children under 2. However, they voted 15-7 against opposing the medications' use for children between 6 and 12. The recommendations must go through the agency's rulemaking procedures, which could take a year or more to finalize. Officials may release an interim statement soon.

However, Mary Tinetti, MD, professor of the Yale University School of Medicine, said: "Conversely, if we add something like 'unless directed by a doctor,' we have defeated the whole rest of the message." She noted that the language will still have to go through considerations at the FDA, but said, "I think the sentiment here is...that they should not be used."

In a move with possibly broad implications, the committee voted against extrapolating efficacy data for adults to children under 12. John Jenkins, MD, director of the FDA Office of New Drugs, in the Center for Drug Evaluation and Research, noted to the media that the advice was in direct contradiction to recommendations the agency got 30 years ago. He also indicated the agency might carry the recommendation over to other drugs.

In a statement to the panels before their voting period, David Bromberg, MD, testified for the American Academy of Pediatrics. "Based on the evidence available in peerreviewed literature, these medications, either singly or in combination, do not work to relieve cough and cold symptoms," for children under six.

The committee also voted unanimously that liquid formulations should be required to have dosing devices standard in wording and dosing. One committee member, Ruth Parker, MD, who is an expert in labeling issues, called for cognitive psychology testing of such wording, "to show that the people who use it understand it."

Parker, associate professor of medicine at Emory University, said variation in the liquids' concentration is likely "a root cause of misunderstanding and misconceptions. And that is an actionable item that could decrease variability and lead to less misunderstanding and less confusion."

The committee members also discussed what should be on the front of these medications' packages. The general sentiment was for listing ingredient names as large as the brand name; stating that children should not take two products with the same ingredients and that the products should not be used to sedate a child; and excluding terms like "doctor recommended" and pictures of young children. The front panel, members said, should also state who should not take the medications.

Parker warned that language also should to be tested for consumer interpretation. "If you warn people not to use two products with the same ingredients, does that mean that if one product contains three ingredients and the other contains two-do they contain the same ingredients?"

The two panels, the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee, are made up of experts from around the country. Most are physicians and professors at schools of medicine. At least six are pediatricians.

Information about the issues and the meeting is at http://www.fda.gov/oc/advisory/ under FDA Science Board: Pediatrics; then under "briefing document."