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September 2007
In a recent public health advisory, FDA officials are urging parents to avoid giving cough and cold products to children younger than aged 2, unless advised otherwise by a physician.
A citizen petition was submitted to the FDA on March 1, 2007, which raised concerns about over-the-counter cough and cold medicine in children aged younger than 6 years.
FDA officials said “reports of serious adverse events with these medications may be the result of giving too much of the medicines to children. An OTC medicine may be harmful if more than the recommended amount is used, if given too often or if more than one cough and cold medicine that contains the same active ingredient are being used.”
The Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee have arranged a meeting to be held on Oct. 18 and 19 to give advice and recommendations on the FDA’s regulatory issues.
Topics of discussion will include the review of efficacy data on the use of cold and cough products in adults and children of any age, safety profile of the products in children, the potential labeling changes recommended by the petitioner and the possible effects of these changes on children and health care providers.
Until then, the FDA suggested parents should know the following:
- Do not use cough and cold products in children aged younger than 2 years, unless told to do so by a health care professional.
- Do not give children medicine that is packaged and made for adults; use products only marketed for use in infants, babies or children.
- Cough and cold medicines come in many different strengths, and if ever unsure about a product, ask a health care provider.
- If other OTC medications are given to the child, the combined usage should be reviewed by a health care provider.
- Read and follow all the directions labeled under the “drug facts” box.
- For liquid products, parents should use the measuring device packaged with each medication that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medications to children.
- If a measuring device is not included with the product, the parent should purchase one at the pharmacy. Be sure that the device’s markings match the dosing of the directions in the “drug facts” box or what is recommended by the health care provider.
- Cold and cough medicines treat the symptoms of the common cold but do not cure the common cold.
- 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.
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