WASHINGTON – In the wake of rising safety concerns, a Food and Drug Administration advisory panel said Friday that children under the age of 6 should not be given over-the-counter cough and cold medicines such as Children’s Tylenol Plus Cold and Johnson & Johnson’s Pediacare.
The panel also recommended that such medications not be sold for use by infants.
Parents of children over the age of 6 could continue to use the medications, according to the panel, which is made up of the FDA’s committees on pediatric and nonprescription drugs. But it urged that clinical trials be held to learn more about the risks and benefits for children between the ages of 2 and 12.
Only 11 clinical studies on the effectiveness of the medicines for children have been published over the past 50 years, according to the FDA, although recent data indicate they are used in about 15 percent of all American homes.
“The committee expressed concern about the lack of studies that positively demonstrate the benefits of these products in children,” said Dr. John K. Jenkins, director of the agency’s office of new drugs.
The FDA is not required to follow advisory panel recommendations, but it usually does. Interim action could be taken quickly. Procedures required for final action could take a year or more.
Last week, pharmacies pulled 14 brands of infant cold and cough medicines from their shelves at the urging of the Consumer Healthcare Products Association, which represents major drug manufacturers.
Watchdog groups and some pediatricians and public health experts have been calling for action, pointing to safety issues and questions about the products’ efficacy.
Between 1969 and 2006, the FDA received 54 reports of children’s deaths linked to decongestants and 69 associated with antihistamines, Rep. Henry Waxman, D-Calif., who chairs the House Committee on Oversight and Investigations, said in a letter to the manufacturers association.
“Today, the advisory committee took a critically important step to protect the public health,” Waxman said. “FDA now needs to act to prevent American children from continuing to be exposed to ineffective and potentially dangerous medicines.”