Cold Meds for Kids Back in the Spotlight

Oct. 2 -- THURSDAY, Oct. 2 (HealthDay News) -- After recommending earlier this year that children under the age of 2 not receive over-the-counter cold medicines, the U.S. Food and Drug Administration on Thursday is meeting with the public to help answer an even more important question: Should kids' cold medicines remain "OTC" at all?

The issue is not a new one for regulatory bodies or the public.

In January, the FDA issued an updated health advisory recommending that over-the-counter (OTC) cough and cold preparations not be used to treat children under the age of 2 due to the possibility of life-threatening complications. These products include decongestants, expectorants, antihistamines and cough suppressants.

Just prior to the advisory, the makers of dozens of cough and cold remedies marketed for infants voluntarily recalled the products.

Despite scant evidence that such remedies are actually effective in children or adults, an estimated 10 percent of American kids take one or more cough and cold medications during a given week.

Yet the preparations can do more harm than good, research suggests.

An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.

And the U.S. Centers for Disease Control and Prevention reported that some 7,000 American children under the age of 11 are treated each year in hospital emergency rooms because of problems with cough and cold medications.

According to Dr. Michael Spigarelli, an assistant professor of pediatrics and internal medicine at Cincinnati Children's Hospital, the recent debate originally stemmed from a lawsuit by a group of pediatricians who felt that cough and cold medicines were unsafe -- or at least never proven to be safe. This led to the FDA's statement earlier this year regarding young children.