"Just wait it out." That's the last thing a parent wants to hear when she has a child with a stuffy nose and miserable cough. But it's precisely what parents may now be told by their pediatricians during cold season. After nearly two decades of dispute within the medical community about the effectiveness and safety of pediatric cough and cold medications, the US Food and Drug Administration (FDA) began advising parents in January 2008 not to use these products for children under two years of age.
UPDATE: In October 2008, the FDA announced its support of the voluntary actions by the Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the-counter cough and cold medicines for children, to label appropriate medicines with "do not use" for children under four years of age.
(EARLIER: In November 2007, the American Academy of Pediatrics (AAP) reinforced earlier cough and cold medication recalls by urging parents not to give these over-the-counter drugs to children under six years of age.)
Ineffective for Infants and Children
According to a November 6, 2007, article in the New England Journal of Medicine, children's antihistamines, decongestants, antitussives, and expectorants have long contained ingredients that, in controlled tests given since 1985, have not proven to be more effective than placebos given in these trials.
"For kids under six, these meds just don't work," says Dr. Greg Germain, MD, a pediatrician and teacher at both the Yale School of Medicine and the University of Connecticut School of Medicine who writes a series on parental medical concerns for BabyZone. And while the New England Journal of Medicine article notes that these medications may possibly be linked to poisoning, cardiac arrhythmias, hallucinations, and even accidental overdose, Dr. Germain says it's the combination of the drugs' ineffectiveness and their overabundance that makes the recent recommendations especially important.
"It's confusing for parents [of very young children] at the pharmacy to see so many products with the same components," Dr. Germain says. "We know for a fact that these ingredients don't work at all for these kids."
In a statement released on January 17, 2008, Dr. Charles Ganley, MD, director of the FDA's Office of Nonprescription Products, reinforces Dr. Germain's warning. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under two [years]," Dr. Ganley says. (The FDA is currently reviewing data for kids ages two to 11.)