Oct. 19, 2007 -- A Food and Drug Administration advisory panel of doctors and health experts decided today there is no evidence that cough and cold medicines for children actually work.
This decision stuns many, as these medicines have been marketed and sold for decades with nearly 4 million doses administered to children last year alone.
Given its findings, the panel could not support the continued use of cough and cold medicines in children under age 6.
The group also agreed that doses of these medicines should be standardized between different brands to avoid confusion and parent error, and that the phrase "doctor recommended" should be taken off the packaging.
"The number of dosing errors are certainly higher in the lower ages, partly because the dosing is not standard," Allison Muller, the clinical managing director of the Poison Control Center at Children's Hospital of Philadelphia, said. "I would expect [the decision] could significantly reduce dosing errors. These products have all sorts of calibrations and people interchange them between products -- it's really confusing. It needs to be clear."
The panel made its decision after two days of testimony, which included an emotional appeal from a father who believes his son's seizures resulted from taking one of these medications as an infant.
"Nothing is going to change the health of my son," Dan Mannello said in his testimony. "But I don't want it to happen to anybody else."
Many doctors are praising the panel's findings, saying the Food and Drug Administration should have made this decision years ago, since cough and cold medicines have never been tested.
"These medicines have been used for so long, but no one has decided to study them until now. As physicians, our job is to first do no harm," Dr. Jennifer Shu, spokeswoman for the American Academy of Pediatrics, said. "If there are any questions about causing harm, we shouldn't be using [these medicines]."
The panel ruled that if these drugs are to have a future, the manufactures, which spend $50 million a year marketing them, must test the medications to prove they are effective in children.
The decision has left many parents wondering what they can do for their children when they're suffering from colds now that the winter months are quickly approaching.
"I personally think I would like to give [the medicines] to [my son] because we have nothing else," mother Demetra Stewart told ABC News.
"It'll be a tough year or two for parents, pediatricians, and young children, but in the end, we'll create a better and safer and more effective treatment milieu that will help many families," Dr. Ian Paul, an associate professor of pediatrics at the Penn State College of Medicine, said.
Doctors do have one other warning for parents -- they should not confuse today's decision on cough and cold medicines with allergy medicine. There is medical evidence that children's allergic symptoms are helped by these other common type of over-the-counter drugs.
"It would be a mistake for antihistamines not to be available for hay fever, allergic rhinitis or food allergic reactions," Paul said. "[Antihistamines] are the first line treatment [for allergies] and should remain the first line treatment."