US warning on giving cough and cold drugs to children under 2

16 August, 2007:

The government of the United States has warned parents against giving cough and cold medicines to children under the age of 2 without a doctor’s prescription.

The move is part of an overall review of the products’ safety and effectiveness for young children.

In the light of questions about benefits and risks of cough and cold medicines, the Food and Drug Administration (FDA) has said its Non-prescription Drugs Advisory Committee will meet on October 18-19, 2007, to discuss the use of cough and cold drugs by children.

The FDA issued a public health advisory that cited serious adverse effects linked to children – particularly those aged 2 and younger – who have received too great a dose of over-the-counter medications for coughs and colds.

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The other recommendations in the FDA advisory included:

Do not use cough and cold products in children under 2 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 ‘paediatric’ use.

Cough and cold medicines come in different strengths. If unsure about the right product for a child, ask a health care provider.
If other medicines, whether 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 to know the active ingredients and the warnings.

For liquid products, parents should use the measuring device that is packaged with each medicine formulation and is marked to deliver the recommended dose.

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The labels on the drugs currently advise parents to consult a doctor before giving the medicines if their child is under the age of 2, but too many parents are failing to heed this advice, the FDA said.

Susan Cruzan, a spokeswoman for the FDA, added: “We continue to see adverse effects associated with the medicines because people are not using them properly.”

If, despite label warnings, parents continue to use the drugs inappropriately in young children, the FDA could take more serious action, like restricting the drugs’ wide availability. Most drugs that have been withdrawn in the past 15 years were taken off the market because doctors and patients failed to heed prominent warnings.

Some prominent paediatricians and public health experts are of the opinion that the FDA’s advisory did not go far enough.

One group petitioned the agency to ban the marketing of the drugs for children under the age of 6, and some said that the medicines should no longer be sold over-the-counter for use in children at all.