In an interview with the New York Times, the head of the FDA's division in charge of nonprescription medications acknowledged that the agency is investigating the use of cough and cold medicines in young children.
The official, Dr. Charles J. Ganley, head of the FDA's Office of Nonprescription Products, was quoted in the article as saying that the agency is “revisiting the risks and benefits of the use of these drugs in children” and that they are “particularly concerned about the use of these drugs in children less than 2 years of age.”
Apparently, the review began in 2006, and his comments now are in response to a petition from public health officials and pediatric experts stating that the drugs are neither safe nor effective in young children.
As we have noted here, serious side effects and deaths have occurred from the use of cough medicines and decongestants in infants and toddlers, both due to overdoses and recommended doses as well. There is no known safe dose in young children, and studies show they have little or no effect on cough and cold symptoms. It is good that the FDA is already reviewing the use of these medicines in infants and toddlers.
