FDA to Scrutinize Children's Cold Medicine
The U.S. Food and Drug Administration (FDA) has warned that children's cold medicines can be deadly if over-used. According to a recent Public Health Advisory, serious adverse events recently reported in conjunction with the use of many common, over-the-counter cold remedies appear to be the result of over-medication. The agency has announced that its Nonprescription Drugs Advisory Committee will meet to discuss the safety and effectiveness of these drugs in October. In the interim, the agency recommends that parents who administer over-the-counter cold remedies to their children adhere to the following safety guidelines:
- "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).
- Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.
- 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 in the “Drug Facts” box. Do not give a child medicine more often or in greater amounts than is stated on the package.
- Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.
- 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. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” box on the package label, or is recommended by the child’s health care provider.
- If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your healthcare provider if you have questions or are confused.
- Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.
- 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."
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- Physician group advises against pediatric cold medicines
- A rise in prescription drug use among teens
- FDA recalls children's Triaminic vapor patch
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