FDA warns parents about cough, cold medicines
Published Friday, August 17, 2007 11:39AM EDT
The U.S. government is warning parents never to give cough and cold medicines to children under the age of two unless instructed to do so by a doctor.
The warning is part of a broad plan to reassess the safety of the medicines, which have been blamed for hundreds of hospitalization and a handful of deaths in U.S. toddlers and infants.
The Food and Drug Administration announced Wednesday it will convene a panel of independent experts on Oct. 18 to discuss whether warnings are warranted or whether sales of the medications should be restricted.
"Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially in children under 2 years of age," the FDA said in a statement.
The labels on infant and children's formulas of cold medications currently advise parents to see a doctor before giving the medicines if their child is under the age of two. But many parents fail to heed this advice, and there have been many overdoses.
The FDA launched the investigation after doctors petitioned the agency in March to review the situation and public health authorities raised concerncs about the products.
One group asked the agency to ban the marketing of the drugs for children under the age of six, and some have said the medicines should no longer be sold over-the-counter for use in children at all.
But drugmakers say the drugs are safe and effective. Gerry Harrington of NDMAC (Nonprescription Drug Manufacturers Association of Canada) notes that all but a small number of children's cough and cold medicines sold in Canada caution consumers not to administer the products to children under the age of two without consulting a doctor.
"This underlines the importance of always reading and following label directions, especially when administering products to children," he says.
Despite label warnings, many parents continue to use the drugs inappropriately in young children. In cases of overdoses, either too much medication was given, it was given too often, or more than one cough and cold medicine containing the same active ingredient were used.
Health Canada is currently assessing the use of cough and cold medication in young children and developing guidelines to promote safe use for this age group, said Ren�e Bergeron, spokesperson for the agency.
The Canadian Paediatric Society advises that over-the-counter cough and cold medicines should not be given to children younger than three years old unless prescribed by your doctor.
They note that decongestants taken by mouth are not very effective and can cause rapid heartbeat or insomnia in children. They also have no effect on coughing.
"Except for pain and fever drugs, there is no proof that [cough and cold medicines] work. In fact, some of the side effects can make your child feel even worse," the Society warns on its website.
The FDA offers this advice in its recent public health advisory:
- Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.
- Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called "pediatric" use).
- If other medicines (over-the-counter or prescription) are being given to a child, the child's healthcare provider should review and approve their combined use.
- Read all of the information in the "Drug Facts" box on the package label so that you know the active ingredients and the warnings. Follow the directions and do not give a child medicine more often or in greater amounts than is stated on the package.
- For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children. If a measuring device is not included with the product, parents should purchase one at the pharmacy.
- If a child's condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.