Cold drugs not advised for children
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.
Children older than 6 could continue to use the medications, according to the panel, which comprises the FDA’s committees on pediatric and nonprescription drugs. But it urged that clinical trials study 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 last 50 years, according to the FDA, although recent data indicate they are used in about 15% of 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 across the country pulled 14 brands of infant cold and cough medicines from their shelves at the urging of the Consumer Healthcare Products Assn., 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 A. Waxman (D-Beverly Hills), chairman of the House Committee on Oversight and Government Reform, said in a letter to the manufacturers association.
The deaths involved prescription and over-the-counter drugs as well as overdoses in children younger than 2, he said.
“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.”
Dr. Richard Pan, vice chairman of the American Academy of Pediatrics in California, said he agreed more studies were needed. “Too many medications that we use have never been really evaluated for use in children,” he said.
Drug companies spend more than $50 million a year marketing cough and cold medicines for children under the age of 6, according to the Prescription Project, a private nonprofit research group in Boston. According to research firm AC Nielsen, sales rose 20% over the last year.
Public Citizen, a watchdog and advocacy group founded by Ralph Nader, has called for a ban on sales of over-the-counter cold and cough medicines for children younger than 12. “There is simply no evidence to support the position that these drugs are safe and effective for children,” said Dr. Peter Lurie, deputy director of the nonprofit’s Health Research Group.
Linda A. Suydam, president of the manufacturers group, on the other hand, said, “The data clearly show that these medicines are very safe when used as directed and that harm to this age group, while very rare, is attributable in most cases to accidental ingestion -- an issue of safekeeping that is best addressed through education.”