FDA Recommendation: No Cold Medicine for Infants or Toddlers
In October 2007, the FDA recommended that no over-the-counter pediatric cough and cold medicines be administered to children under age 2 due to the risk of serious and life-threatening side effects including rapid heart rates, convulsions and loss of consciousness. The American Academy of Pediatrics has extended this to recommended against using them in children under age 3 unless advised by a doctor.
In response to the FDA studies, many pharmaceutical manufacturers voluntarily withdrew cough and cold medicines labeled for “infants.” However, many liquid formulations for older children remain on the market and parents may be tempted to administer these to their sick infants.
Most reports of serious problems came from parents accidentally overdosing children by combining multiple medicines or inaccurately measuring dosages in the provided droppers or cups. The FDA is committed to completing a comprehensive review of the safety of these medicines in children 2 years of age and older and will communicate their recommendations to the public as quickly as possible.
Since most colds are indeed self-limiting and there is no evidence that children’s cold medicines are effective in relieving cold symptoms in infants and toddlers, inviting the risks associated with these medicines is unwarranted.
The FDA is continuing to investigate this issue, with concerns that pediatric cold medicines for older children might need to be banned as well.
Here are the FDA recommendations:
- 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.
- 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 health care 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 health care 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.
A Few Care2 Natural Tips
Maintain good indoor air quality to minimize contributions to respiratory infection. Take the Seventh Generation Indoor Air Test
to see how clean the air in your home is.
Use an aromatherapy diffuser to purify the air in your home, possibly helping to prevent the development of colds.
Click here for tips and treatments.
By Terri-Hall Jackson, contributing writer to Care2's Green Living