The Food and Drug Administration will review the drugs, after a petition filed by Baltimore public health officials and others on Thursday.
It's far from the first warning about tots using decongestants and other cold relievers. The American Academy of Pediatrics began issuing those warnings to parents in 1997. And just two months ago, the Centers for Disease Control and Prevention reported that more than 1,500 toddlers and babies wound up in emergency rooms over a two-year period because of the drugs — and told parents not to give the remedies to children under age 2 without consulting a doctor first.
In fact, the labels of every cough and cold remedy caution parents to do just that. The FDA has never approved dosing recommendations for that age group. Nor is it known just how much of various ingredients it takes to injure or kill children that young.
The petition asks the FDA to go further — and require that labels say the products shouldn't be used to treat children younger than 6.
In Maryland alone, roughly 900 children 4 and younger overdosed on the medicines in 2004, according to the new petition. In Baltimore, the medical examiner has linked the products to the deaths of at least four children under 4 in the last five years.
Yet these products have never been proven to benefit children so young, the petitioners, including pediatricians from around the country, argued.
Therefore, "we recommend that families be aware of these risks and not use over-the-counter cough and cold medications for children ages 5 and under," Baltimore officials said.
"We've asked the FDA to make a clear statement to the public that these products have not been proven safe and effective for your children and to advise parents not to give them to young children," Dr. Joshua Sharfstein, Health Commissioner of Baltimore, told CBS News medical correspondent Dr. Jon LaPook.
The petitioners said the average drug store stocks more than 30 such products, many of which include labels splashed with images of babies or toddlers.
The FDA planned a teleconference later Friday to its planned review, first reported by The New York Times.
Dr. Charles J. Ganley, director of the FDA's office of nonprescription drug products, told the Times that "we're particularly concerned about the use of these drugs in children less than 2 years of age."
What many people may not realize is that the childhood recommendations for cold and cough medicines are based on studies done in adults, LaPook reports. The dosage is then lowered based on reasonable estimates rather than on studies done on the kids themselves.
Parents already can see the vital under-2 warning on these products' labels, said Linda A. Suydam, president of the Consumer Healthcare Products Association, which represents makers of over-the-counter, or OTC, medicines.
"OTC cough and cold remedies have a long history of safety when used according to the label. The most important information for all consumers is that OTC medicines are real medicines and must be used according to the label instructions at all times," Suydam said in a statement Friday.
Parents commonly use the cold and cough preparations to treat their children, who suffer on average from six to 10 colds a year. A 1994 report in the Journal of the American Medical Association suggested that in a specific 30-day period, nearly 36 percent of all 3-year-olds in the United States were given nonprescription cough and cold medications.