To Dose or Not to Dose?
The down and dirty on Cough Medicine Alerts.
by Janell Gulstad
Recent studies and government mandates making headlines have resulted in a lot of anxiety about what cold and cough remedies you can, or should, give your child. Confused about the news? Here’s an overview of the cough medicine controversy.
Until fairly recently, cough and multi-symptom cold medicines were formulated in the same way for adults and children, on the assumption that their physiology was the same. Comparatively little research had been done on how these medicines work in children.
The debate over the effectiveness of over-the-counter cough medicines has actually been around for at least a couple of decades, but it seemed to get hotter in 2002 with a study published in the British Medical Journal. In that report, researchers determined that OTC cough medicines don’t work for adults. New studies began to show that these medicines can actually be harmful for children under age two, and called into question how effective they are for children of any age.
One such analysis was a widely-reported Penn State College of Medicine study, published in 2004, which found that, for children over 1-year-old, a small dose of buckwheat honey may do a better job of relieving nighttime cough than dextromethorphan, the main ingredient in most OTC cough medicines. (This is not to be confused with clover honey, the primary type sold in grocery stores. Honey should never be given to an infant who is less than a year old.)
In their defense, several other recent studies have shown cough and cold medicines to be effective in children who are 2-years-old and up, as well as in adults. However, in 2006, two significant reports were published, by the American Academy of Chest Physicians and the Cochrane Review, both of which assessed the existing research. Neither review found enough evidence to endorse the use of OTC cough and cold remedies.
Then, in March 2007, a public petition was filed with the U.S. Food and Drug Administration (FDA) to address the issue and to ban these medicines for children under 11.
Shortly before the FDA hearing in October, the Consumer Healthcare Products Association (CHPA) announced that its members would voluntarily remove about 200 brands of OTC cold and cough medicines designated for infants, modify labels on pediatric medicines warning against their use for children under 2 and cautioning their use with children under 6. Some of the affected brands that disappeared from store shelves were Tylenol Infant Drops Plus Cold, Triaminic Infant and Little Colds.
Days later, an FDA advisory panel heard the public petition and recommended that the agency ban these products for children under the age of 6.
As a result of this review, in January 2008 the FDA issued a Public Health Advisory recommending “that these drugs not be used to treat children and infants under the age of 2.” The advisory states that FDA will complete a thorough review as soon as possible.
Also last month, the FDA issued another Public Health Advisory on a related topic. The gist of the latest report is this: each year, more than 7,000 children aged 11 and under end up in emergency rooms because of cold and cough medicine overdose. About two-thirds of these are cases where children ingest the medicine “without adult supervision” and more than half of all the cases are children under 6.
That brings us up to date and perhaps back to your coughing child’s bedside in the middle of the night. Are cough medicines effective? The answer still depends on whom you ask. Your child’s pediatrician may have prescribed medicine, or may even have suggested an OTC remedy that you feel comfortable and confident using. Current research is showing that most of the danger to children from these medicines seems to be from improper dosing and/or combining medicines, so measure carefully and read the labels.
And tomorrow night, try some buckwheat honey.
Want to know more? You may be interested in these links:
American Academy of Pediatricians
OTCsafety (Consumer Health Products Association outreach effort)
FDA Public Health Advisory
Center for Disease Control - Cold and Cough Medicine