Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children - Overview
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Welcome to the Food and Drug Administration's drug safety update.
I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.
On January 17, 2008 we issued a public health advisory titled: FDA Recommends that Over-the-Counter Cough and Cold Products not be used for Children under Two-Years-of-Age.
FDA is recommending that over-the-counter, also known as OTC, cough and cold medicines not be used to treat infants and children under two-years-of-age because serious and potentially life-threatening side effects can occur.
We are aware of reports of serious side effects from OTC cough and cold medicines in children two-years-of-age and older. FDA is committed to completing its comprehensive and thorough review of the safety of OTC cough and cold medicines in children two-years-of-age and older as quickly as possible and expects to communicate our recommendations to the public in the near future.
Pending completion of FDA's ongoing review, if parents and caregivers use OTC cough and cold medicines in children two-years-of-age and older, FDA recommends:
- Checking the "active ingredients" section of the DRUG FACTS label. This will help you understand what "active ingredients" are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one "active ingredient" (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).
- Being very careful if you are giving more than one OTC cough and cold medicine to a child. Many OTC cough and cold medicines have more than one "active ingredient." If you use two medicines that have the same or similar "active ingredients" a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.
- Carefully following the directions in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it.
- Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.
- Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.
- Understanding that using OTC cough and cold medicines are intended only to treat your child's symptoms. OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick. They only relieve symptoms and make your child feel more comfortable.
- Not using these products to sedate your child or make children sleepy.
- Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children two- years-of-age and older.
To hear the full public health advisory, listen to part two of this broadcast.
We urge parents, caregivers and healthcare providers to report side effects that may be associated with the use of OTC cough and cold medicines in children two-years-of-age and older to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Date created: January 18, 2008
Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children - Overview mp3(MP3 - 1.9MB) Use of Over-the-Counter (OTC) Cough and Cold Products in Infants and Children - Full Version Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age