OTC Cough And Cold Medicines Not Recommended For Infants Says FDA

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pediatrics / Children's Health;  Respiratory / Asthma
Article Date: 18 Jan 2008 - 3:00 PDT

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The US Food and Drug Administration (FDA) issued a Public Health Advisory for parents and caregivers yesterday, Thursday 17th January, recommending they do not give over the counter (OTC) cough and cold medicines to infants younger than 2 because they can lead to serious and fatal side effects.

In a statement to the press, the agency intimated it did not rule out making such a recommendation for older children in the future, when it has completed its evaluation in older populations.

OTC cough and cold medicines include decongestants, expectorants, antihistamines, and cough suppressants (antitussives) for treating colds.

Dr Charles Ganley, director of the FDA's Office of Nonprescription Products, said:

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2."

"These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2," he added.

The agency decided to make the announcement following the results of two surveys that showed parents and caregivers were still giving these medicines to children under 2 years old, and some did not know about the side effects.

Reported side effects of using these drugs with small children include death, rapid pulse, convulsions, and varying degrees of loss of consciousness.

The agency said it was still reviewing the evidence for older children, from 2 to 11, and plans to issue its recommendations soon, it said in a statement also released yesterday.

The Advisory follows a review and discussion by the joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees in October last year.

In the meantime, parents and caregivers of children aged 2 to 11, should be extremely careful about giving them OTC cough and cold drugs, and should contact their doctor, pharmacist or other health care professional about what drugs, if any, they should give to a child with a cough or cold.

In particular, the FDA advised parents intending to treat their 2 to 11 year old with OTC cough and cold drugs:

• Do not deviate from the label's dosing instructions.


• Note that the drug will not cure or shorten the duration of the illness.


• Check the "Drug Facts" on the label and note there could be more active ingredients than you assumed.


• Do not use any other measuring spoon or cup than the one that comes with the product.


• Never use a cough or cold remedy to sedate or make your child sleepy.

Some doctors' groups expressed disappointment that the FDA advisory did not cover older children.

President of the National Research Center for Women and Families, Diana Zuckerman told the New York Times:

"The delay enables major drug companies to continue to make millions of dollars selling families children's cold and cough medications that have never been proven effective."

According to the paper, there are around 800 pediatric cough and cold drugs on sale in the US, containing one or more of 30 different active ingredients. American parents spend about half a billion dollars a year on nearly 4 billion doses.

Even the American College of Chest Physicians does not recommend the use of pediatric cold medicines.

It is being speculated in the media that the FDA will raise the age limit to 6 sometime in the spring.

Many of the major drug companies voluntarily withdrew their infant cough and cold medicines three months ago, and most US pharmacies stopped stocking them around the same time.

There's a chance however that many parents may still have the medicines at home, and be tempted to use them, a representative of the American Society of Health-System Pharmacists Research and Education Foundation told Business Week.

Also, it is possible that parents are giving drugs intended for older children to infants, and the surveys conducted recently would tend to support this as many parents said they believed OTC cough and cold medicines for children and infants were safe.

An FDA advisory panel met in October last year and recommended that cough and cold drugs were not safe for children under 6. This was followed by an article in the New England Journal of Medicine in December, recommending the agency impose a ban on the drugs.

Click here for the full Public Health Advisory (FDA).

Click here for Questions and Answers for Consumers (FDA).

Sources: FDA, New York Times, Business Week, NEJM, Medical News Today Archive.

Written by: Catharine Paddock
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today