Family physicians should alert the parents of their younger patients that the FDA has issued a public health advisory regarding the use of over-the-counter, or OTC, cough and cold medications for children.
FDA Advisory
Warn Parents About Dangers Cold Medicines Pose for Kids
By News Staff
8/22/2007
"Do not use cough and cold products in children under 2 years of age, unless given specific directions to do so by a health care provider," the advisory says. "Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger."
The Aug. 15 advisory tells parents to use only products marked for use in babies, infants and children. Such products are sometimes packaged as pediatric formulas.
In addition, the advisory offers some advice.
The Aug. 15 advisory tells parents to use only products marked for use in babies, infants and children. Such products are sometimes packaged as pediatric formulas.
In addition, the advisory offers some advice.
- "Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a health care provider.
- "If other medicines (OTC or prescription) are being given to a child, the child's health care 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 in the 'Drug Facts' box. 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 you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device, … DO NOT USE the medicine. Consult your health care provider if you have questions or are confused."
The advisory reminds parents that cough and cold medicines only treat cold symptoms and do not cure colds. It also recommends that if a child's condition worsens or fails to improve with time, parents should take the child to a health care professional for evaluation.
"Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children," the advisory says.
Neurological problems, such as seizures and loss of consciousness, have been attributed to dextromethorphan -- an ingredient often included in cold medications -- and pseudoephedrine, another common ingredient, has been associated with infant deaths, increased blood pressure and arrhythmias.
The FDA will convene its Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee Oct. 18-19 to discuss the safety and effectiveness of cough and cold medicines.
"Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children," the advisory says.
Neurological problems, such as seizures and loss of consciousness, have been attributed to dextromethorphan -- an ingredient often included in cold medications -- and pseudoephedrine, another common ingredient, has been associated with infant deaths, increased blood pressure and arrhythmias.
The FDA will convene its Nonprescription Drugs Advisory Committee and its Pediatric Advisory Committee Oct. 18-19 to discuss the safety and effectiveness of cough and cold medicines.
