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Cold Medicine Warning Issued for Children
download the complete newsletterThe U.S. Food and Drug Administration (FDA) has warned against giving overthe- counter cold and cough medicines to children under the age of 2 after reports of “serious and potentially life-threatening side effects” in babies and toddlers. A UCLA expert notes that these remedies were unlikely to provide much help anyway.
“There has never been good evidence that cough and cold medicines work. And for children under 2 there is the added concern that we don’t have good information about proper dosages,” says Dennis Woo, M.D., chairman of pediatrics at UCLA Medical Center, Santa Monica. “When the potential dangers came to light, it made sense to issue this statement.”
The FDA warning came after a year of review following reports by the Centers for Disease Control and Prevention that linked the deaths of three babies, and hundreds of emergency room visits, to reactions to the cough and cold medicines. Risks of toxic reactions such as convulsions, increased heart rates and lowered levels of consciousness are particularly great for the youngest patients when they receive doses that are too high, or are given the medication too often.
“Without any good information on what the correct dose was for infants and toddlers, people tended to extrapolate based on what was known about adult doses, but babies’ organ systems are different,” says Edgar Arriola, Pharm.D., coordinator of UCLA’s Drug Information Center. “In addition, there are many over-the-counter and prescription medications with overlapping ingredients, putting babies and toddlers at further risk of getting dangerously high doses.”
Cough and cold medicines labeled for babies and toddlers have been pulled from the shelves since October 2007, but Dr. Woo notes that the products can still be found in many people’s medicine cabinets. Further, although the dosing labels tell parents to consult their pediatrician about how much to give to children under 2, many parents faced with an uncomfortable child fail to take the time to do so.
Although the FDA recommendation applies only to infants and toddlers, the agency is continuing to review research on the safety and effectiveness of cough and cold medicines in children ages 2-11 years old. Dr. Woo recommends that patients not be given the medications until they are older than 5, and then only once at bedtime if it seems to provide symptomatic relief.
“The bottom line is that nothing makes colds go away any faster,” he says. “In some cases it may mask the symptoms, but children under 2 should never be given these medications, and for those older than 2, we need to be very careful.”
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