No over-the-counter cold medicines for toddlers'

By Johnny Jackson


With the recent wintery blitz sweeping through metro Atlanta, parents with sickly children are looking for ways to keep them healthy during the cold and flu season.

On Thursday, the U.S. Food and Drug Administration issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter cough and cold products should not be used to treat infants and children less than 2 years of age, because serious and potentially life-threatening side effects can occur.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

Products on the not-for-toddlers list, include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

Parents with small children should first consult with their child's physician, said Joel Maddox, a McDonough pharmacist of 30 years.

"I always recommend that they contact their pediatrician," Maddox said. "In a lot of cases, pediatricians will dose down [in cough and cold medications]."

FDA officials say a wide variety of rare, but serious adverse events have been reported with cough and cold products, including death, convulsions, rapid heart rates, and decreased levels of consciousness.

The announcement does not include the FDA's final recommendation about use of cough and cold medicines in children ages 2 to 11 years, however. The agency's review of data for 2-to-11-year-olds is continuing. The agency plans to issue its recommendations on use of the products in those children as soon as the review is complete.

Meanwhile, FDA officials recommend parents and caregivers who choose to use over the counter cough and cold medicines to children ages 2 to 11 years do the following: follow the dosage directions on the label; understand that these drugs will NOT cure or shorten the duration of the common cold; check the "Drug Facts" label to learn what active ingredients are in the products, because many of them contain multiple active ingredients; and use only measuring spoons, or cups, that come with the medicine or those made specially for measuring drugs.

A rule of thumb for parents caring for their children, sick or healthy, is good hygiene, said pharmacist Maddox. "The parents want to wash their hands; the more hand-washing the better off," he said. "And keep healthy children away from sick children."

The FDA recommends that anyone with questions contact a physician, pharmacist, or other health-care professional to discuss how to treat a child with a cough or cold.

For more information, and a full list of FDA "cough or cold" recommendations, visit the web site at www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.