By Jane Hart, MD
Healthnotes Newswire (November 29, 2007)—Following reports of serious injuries and deaths in children treated with cold medicines, the health community and industry has waited expectantly for the US Food and Drug Administration to weigh in on the issue. The FDA’s announcement in August of its plans to conduct a hearing prompted many manufacturers to voluntarily remove children’s cold medicines from store shelves. Now, the much-anticipated hearing has led the FDA to conclude that, until more research is conducted that shows safety and efficacy, these medicines should not be given to children under two years old unless instructed by a healthcare provider.
The limited number of available studies on the use of cough and cold medicine in children has not demonstrated effectiveness, according to information presented at the FDA hearing. Some cough and cold products currently on the market have never been tested in children.
Despite the lack of scientific evidence, manufacturers still claim their products’ effectiveness on the label and in the media. Linda A. Suydam, president of the Consumer Healthcare Products Association, said that over-the-counter cold medicines provide “real comfort” to children who suffer from cold symptoms. She stated that harm in children, while rare, is usually attributable to accidental ingestion, “an issue of safekeeping that is best addressed through education.” In other words, it is important to store medicines safely out of children’s reach and to administer them properly. (For more tips on safe administration, see the end of this article.) Suydam said that the Consumer Healthcare Products Association will work with the FDA to ensure sufficient scientific evidence of these products’ efficacy.
Taking care of your ailing child
Natural remedies, such as vitamin C, are an option for parents looking for ways to soothe their children’s cold symptoms. “Taking vitamin C two or three times a day for several days has been shown to shorten the duration of colds and the severity of symptoms in children,” said Alan R. Gaby, MD, chief science editor for Healthnotes. “However, two other cold remedies that are effective in adults—echinacea and zinc lozenges—do not appear to work for children.” The appropriate amount of vitamin C for children varies depending on age and tolerance and should be discussed with a healthcare professional.
This new attention on medications may signal a return to the old-fashioned, common sense remedies many parents grew up with:
• Make sure your child gets plenty of fluids intake in order to maintain water balance and to thin secretions. Avoid sugary drinks in favor of water or a comforting chicken broth.
• Avoid giving sick children sugar and excessively fatty foods, as they are known to dip immune function.
• A warm, humid environment created by a humidifier may provide some comfort while riding out a cold.
• Make sure your sick child gets pleny of rest, especially those with severe symptoms.
Cold medicine dos and don’ts
The FDA made the following recommendations for parents who may continue to administer over-the-counter cold medicines to their children:
• Do not use cough and cold products in children under two years old unless given specific directions to do so by a healthcare provider.
• Read all of the information in the “Drug Facts” box on the product label.
• Do not give children medicine more often or in greater amounts than what is listed on the product label and use only as directed.
• Do not give children medication that is intended for adult use.
• Be aware that using various cough and cold medicines in combination may pose health risks; parents should ask a doctor whether or not it is safe to use products in combination.
• Use appropriate measuring devices such as a dropper or dosing spoon; parents should contact their doctor or pharmacist if they do not understand the dosing directions.
Finally, the FDA reminds parents that medicines used to treat cold symptoms do not cure a cold and that, even without treating symptoms, children will get better with time.
(Sources: FDA Public Health Advisory www.fda.gov/cder/drug/advisory/cough_cold.htm
FDA Hearing Presentation www.fda.gov/ohrms/dockets/ac/07/slides/2007-4323s1-03-Petitioner-Sharfstein.ppt
Consumer Healthcare Products Association Statement www.chpa-info.org/ChpaPortal/PressRoom/NewsReleases/2007/07_20_CHPA_Ad_Comm_Statement.htm)
Jane Hart, MD, board-certified in internal medicine, serves in a variety of professional roles including consultant, journalist, and educator. Dr. Hart, a Clinical Instructor at Case Medical School in Cleveland, Ohio, writes extensively about health and wellness and a variety of other topics for nationally recognized organizations, Web sites, and print publications. Sought out for her expertise in the areas of integrative and preventive medicine, she is frequently quoted by national and local media. Dr. Hart is a professional lecturer for healthcare professionals, consumers, and youth and is a regular corporate speaker.
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