Federal regulators are planning to launch a broad new review of whether over-the-counter cold medicines are safe and effective for children under 12.
The Food and Drug Administration said yesterday that it will hold public hearings on the medications in October, the first step in what will likely be a long study that could lead to stricter age guidelines, changes in formulas and recommended dosages, and the removal of some products from the market, said Dr. Janet Woodcock, director of the FDA's center for drug evaluation and research.
"We know that one in 10 children in any day of the week is on these medicines. They are very widely used, and they deserve to have modern evidence," she said.
"If the evidence is negative, then they shouldn't be available."
In January, the federal agency urged parents to stop giving such medicines to children under 2, after warnings by medical experts that they could do infants more harm than good.
That decision came on the heels of an aggressive effort by Baltimore Health Commissioner Joshua M. Sharfstein and a group of leading pediatricians to push the FDA to look closely at child cough and cold medications.
Last fall, a federal advisory committee recommended that the remedies should not be given to children under 6 and found no evidence that they are effective in children under 12.
The panel suggested companies change the wording on labels of the syrups and drops from "Consult a Physician" to "Do Not Use," and objected to the phrase "Pediatrician Recommended" that appears on packaging.
The panel also recommended the industry conduct trials to determine the safety and effectiveness of the medicines in children.
Woodcock said that when the syrups and drops came on the market in the 1970s, the FDA did not require them to be tested on children. Given mounting concerns, FDA officials now think that the medicines should be subject to more rigorous standards.
"For children under 12, these medicines were not studied by modern standards," Woodcock said. "Back in that time, there weren't special clinical trials in children.
"But the new science in children tells us it is actually necessary to study children to be certain we are giving the right dose, to measure the side effects and the effectiveness.
"We believe these drugs need to be conformed to modern standards."
Industry reassures
