Cold Remedies Put Children At Risk, Leading Pediatricians Say
A group of leading pediatricians have petitioned the Food and Drug Administration (FDA) to stop drug makers from marketing over-the-counter cough and cold remedies to children.
In some children, unintentional overdoses have caused heart rhythm changes, cardiopulmonary arrest, hallucinations, psychoses, hypertension and seizures, according to research cited in the petition.
“Over-the-counter cough and cold preparations are neither safe nor effective for use in young children,” the petitioners argue. “The FDA has never conducted an appropriate analysis to support their widespread use, and expert organizations agree that they are ineffective and pose a risk to health.”
The petitioners urged the FDA to tell drugmakers the continued marketing of such products for infants and young children is not supported by scientific evidence and should lead to enforcement actions against the makers.
Dr. Joshua Sharfstein, Baltimore’s commissioner of health, led the group of 15 petitioners who include such pediatric luminaries as Dr. Janet Serwint, professor of pediatrics at the Johns Hopkins University; Dr. Steven J. Czinn, chairman of pediatrics at the University of Maryland School of Medicine; and Dr. Michael Shannon, professor of pediatrics at Harvard Medical School.
“These are very senior pediatricians,” Sharfstein said. “That kind of expertise is not something the FDA gets petitions from every day.
“I think this is something that should be wrapped up fairly quickly because the evidence on this is clear. They don’t work, and they’re not safe,” he said.
FDA Says No Need for Immediate Action
FDA officials have replied that the agency plans to review the matter over the next several months. One official told reporters at a Washington briefing that there is no need for immediate action.
Dr. Charles Ganley, director of the Office of Nonprescription Products said the review will include an assessment of the safety and efficacy of cold and cough medications for children, as well as how dosage levels for them are drawn up. In the meantime, he said, parents should be careful to follow directions on the products.
“If we thought there was a need to come out with an immediate statement, we would do so,” Ganley said. “Parents need to adhere to those dosing directions. If the directions are to consult a physician, parents need to adhere to that.”