As the season for colds and flu approaches, drug makers have announced they are changing their product labeling to caution parents against using cough and cold formulas for children younger than 4. Pediatricians say home remedies may be better.
The Food and Drug Administration and the drug industry have been grappling with safety concerns about cough and cold formulas for more than a year. In January, the FDA advised parents not to give the medications to babies. Many pediatricians worried that the drugs can cause more harm than good in older children, too. Every year, thousands of children end up in hospital emergency rooms with breathing problems, dizziness and high blood pressure.
That's why the industry is now changing its product labeling for toddlers. Linda Suydam, president of the Consumer Healthcare Products Association, which represents companies that sell over-the-counter medications, says 2- and 3-year-olds are the most vulnerable.
"Accidental ingestions are the result of curious toddlers getting into medications that are left out in a place where they can reach them and take them and overdose," she says.
That, along with parents who accidentally give children a double dose of medication. "We are actually on the packages now putting the active ingredients in bold letters on the front of the package, so parents know when they pick up the package that they should not use another product that contains that same active ingredient," Suydam says.
Part of the reason for these changes has to do with a lack of understanding about how the drugs work in children.
"These medications have never been studied in children, and they've never been studied for their efficacy or for their safety," says Dr. David Bromberg, a pediatrician who represents the American Academy of Pediatrics. "With no shown efficacy, the concerns are that any safety problems are unacceptable."
Pediatrician Joshua Sharfstein, Baltimore's health commissioner, says the new labels are a good start. But he worries that for the next few months, there will be a mix of products on drugstore shelves — some with old labels and some with new. That could be confusing, he says.
"When I went into the pharmacy in Baltimore yesterday, I saw some products saying 'Do not use under 4,' and some products saying 'Talk to your doctor if you want to use under 2,' so there's a huge variety out there," he says. "Some of the boxes say 'Pediatrician recommended,' even though the American Academy of Pediatrics believes these products should not be used [for any children] under age 6."
The industry is now starting studies to look more closely at whether the drugs work in children of various ages. And the FDA is continuing its review of the drugs' safety.
In the meantime, pediatricians like Bromberg suggest that parents check with their children's doctor if they're confused about what to do, and try a home remedy instead of reaching for the medicine.
Recent studies have suggested that — for children older than 12 months — honey may be an effective remedy in soothing the throat and stopping the cough reflex, Bromberg says. Younger babies should never be given honey.
"Humidity and fluids," he says, "also help to minimize some of the effects of nasal secretions."
So parents of kids with the sniffles might want to try a humidifier in their room.