FDA Reviews OTC Cough And Cold Remedies For Kids

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Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals;  Respiratory / Asthma
Article Date: 02 Oct 2008 - 11:00 PDT

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As part of a review of the rules on the use of over-the-counter (OTC) cough and cold medications for children, the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research is holding an all day meeting in Beltsville, Maryland, today, Thursday, to hear what the public has to say about them.

Earlier this year the agency warned that OTC cough and cold medicines should not be given to children under 2 years of age. They said then they would be reviewing their advice for children up to the age of 11. The process for doing that is now under way, and today's hearing is part of it. Manufacturers voluntarily stopped marketing cough and cold medicines for children under 2 before winter last year.

The FDA is interested in obtaining the public view on a number questions. These include:

1. What types of studies should be done to assess safety, effectiveness and dosing of kids' cough and cold OTC medicines?


2. Should they still be available over the counter or only via prescription for kids?


3. Would banning OTC use of kids' formulas increase use of adult formulas and thus put kids at greater risk of misuse and overdose?


4. Do the answers to these questions depend on the age of the kids?


5. FDA currently extrapolates data from adult studies to establish safety and efficacy of these drugs for children over 12. Is it still appropriate to say children of 12 and over should have the same dose as adults, without doing further studies of children in this age group? If not, then what further studies should be done?


6. Should products be dosed by age, by weight, or both?


7. Are the answers to these questions different for subcategories of these medicines (eg topical or intranasal products)?


8. What about combining drugs: should combinations be permitted for all kids' age groups, and should data be provided to support each unique combination?


9. What is the best way to reduce measurement errors? Can this be done by using more standardized measuring devices or alternative types of dosage?

According to a report by the Associated Press, pediatricians are putting pressure on the FDA to recall all OTC cough and cold medicines for children under 6 years of age. They say most colds clear up on their own after a few days and the only treatment needed is rest and plenty of fluids.

Baltimore's commissioner for health, Dr Joshua Sharfstein said in an interview that parents should be aware there is very little evidence to support OTC cough and cold medicines for young children.

The market for OTC cough and cold medicines for children is worth about 286 million dollars a year, said the AP report quoting estimates from market researchers Nielsen Co.

About 7,000 children end up in hospital every year in the US because of incorrect use of cough and cold medicines, mostly due to unintentional overdose. Sometimes parents don't realize that two different products, for example a cough syrup and a decongestant, share the same ingredients. They give the child a dose of each, and this becomes an overdose.

One of the difficulties faced by the agency is that it is harder for the FDA to restrict use of OTC products compared to prescription drugs. They have to persuade manufacturers to voluntarily stop selling or recall the products.

Many OTC medicines like decongestants, antihistamines, and cough and cold remedies can be marketed in the US without FDA approval as long as their ingredients meet rules that are "generally recognized as safe and effective", said a report in CNN. One ingredient that falls under this rule is the decongestant phenylephrine.

Industry groups representing the manufacturers told the press that it was not the safety of the ingredients that was the problem but the way people were using them. They say their OTC cough and cold remedies are safe and effective in children over 2 years old, and support improved consumer education. However, they also support more research into OTC drugs in children.

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Source: FDA, CNN, Associated Press.

Written by: Catharine Paddock, PhD.


Copyright: Medical News Today
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