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As colds and flu season approaches, the drug makers say they will change their product labeling for cough and cold formulas. The labels will now caution parents against giving the medicine to children under age four. Pediatricians say home remedies may be better. NPR's Patti Neighmond reports.
PATTI NEIGHMOND: The Food and Drug Administration and the drug industry have been grappling with safety concerns about cough and cold formulas for over a year. In January, the FDA advised parents not to use the medications with babies. Many pediatricians worried the drugs can cause more harm than good in older children, too. Every year, thousands of children end up in hospital E.R.'s with breathing problems, dizziness and high blood pressure. That's why the industry is now changing its product labeling for toddlers. Linda Suydam, is president of the Consumer Healthcare Products Association, which represents companies that sell over-the-counter medications. Suydam says two and three year-olds are the most vulnerable.
Ms. LINDA SUYDAM (President, Comsumer Healtcare Products Association): Accidental ingestions are the result of curious toddlers getting into medications that are left out in a place where they can reach them.
NEIGHMOND: That, along with parents who accidentally give children a double dose of medication.
Ms. SUYDAM: 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.
NEIGHMOND: Part of the reason for these changes has to do with a lack of understanding about how the medications work in children. Dr. David Bromberg is a pediatrician who represents the American Academy of Pediatrics.
Dr. DAVID BROMBERG (Pediatrician, American Academy of Pediatrics): These medications have never been studied in children, and they've never been studied for their efficacy or for their safety. And with no shown efficacy, the concerns are that any safety problems are unacceptable.
NEIGHMOND: Pediatrician Joshua Sharfstein, is commissioner of health in Baltimore, Maryland. He says the new labels are a good start. But he worries that for the next few months, there'll be a mix of products on drugstore shelves - some with old labels and some with new and that could be confusing.
Dr. JOSHUA SHARFSTEIN (Commissioner of Health, Baltimore, Maryland): When I went to the pharmacy in Baltimore yesterday, I saw some products saying do not use under four, and some products saying talk to your doctor if your want to use under two, so there's a huge variety out there. Some of the boxes say pediatrician recommended, even though the American Academy of Pediatrics believes these products should not be used under age six.
NEIGHMOND: 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 Dr. Bromberg suggest checking with your doctor if you're confused about what to do when your child gets a cold and try a home remedy instead of reaching for the medicine.
Dr. BROMBERG: Recent studies have suggested that honey may be a very effective remedy in soothing the throat and stopping the cough reflex. Humidity and fluids also help to minimize some of the effects of nasal secretion. [POST-BROADCAST CORRECTION: Honey should never be given to children younger than 12 months old.]
NEIGHMOND: So parents get out the tea and honey and put a humidifier in your child's room. Patti Neighmond, NPR News.
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