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FDA Warns on Tots' Cough, Cold Drug Use

FDA: Don’t Give Cough or Cold Medicines to Kids Under 2 Unless Told to Do So By a Health Care Provider

Medically Reviewed by Louise Chang, MD on August 16, 2007
From the WebMD Archives

Aug. 16, 2007 -- The FDA is warning parents not to give children younger than 2 over-the-counter cough or cold medicines unless given specific directions to do so by a health care provider.

The FDA is reviewing the safety and effectiveness of nonprescription cough and cold drug use in children. An FDA panel will discuss the topic in October.

The FDA yesterday issued a public health advisory stating that "questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially children under 2 years of age."

In the advisory, the FDA warns that "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 FDA stresses the importance of following directions for use noted in the "Drug Facts" box on the product label.

"An over-the-counter cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used," states the FDA.

FDA's Advice

The FDA's public health advisory includes the following advice for parents about using cough and cold products in children:

  • 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 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.
  • 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.

Industry Responds

WebMD contacted the Consumer Healthcare Products Association (CHPA), a trade group representing U.S. makers and distributors of over-the-counter (OTC) medicines and nutritional supplement products, for its response to the FDA's public health advisory.

The CHPA replied with an emailed statement from Linda Suydam, DPA, CHPA president.

In the statement, Suydam says: “Millions of Americans safely and effectively use OTC cough and cold medicines every year, both for themselves and for their families. These medicines have been found safe and effective by the U.S. Food and Drug Administration (FDA) and are the same medications families have trusted for decades to help relieve cough and cold symptoms and make their children feel better.

“Parents know they can rely on safe and effective OTC cough and cold remedies when treating their children, but must do so according to label directions. As with all medicines, not following the label can result in harm to children. We know that adverse events can be the result of parents giving too much medicine to their children. OTC cough and cold medicine labels contain detailed information to help parents correctly medicate their children, including an instruction to contact a physician before giving the medication to a child under the age of two.

“We commend FDA on its commitment to ensuring American parents have quality medicines and the information to use them correctly when caring for children. We look forward to working closely with the agency and the healthcare community on this very important issue and at FDA’s October meeting of its expert advisory committee.“

Show Sources

SOURCES: FDA, News release. FDA: "Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children," Aug. 15, 2007. WebMD Medical News: "FDA Reviewing Cold Drug Safety in Kids." Consumer Healthcare Products Association: "Statement from the Consumer Healthcare Product Association on the Safety and Efficacy of Pediatric Cold Medicines."

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