Health: Ban Sought on Cold Medicine for Very Young

[Guest guest]

Ban Sought on Cold Medicine for Very Young

By GARDINER HARRIS

Published: September 29, 2007

 

WASHINGTON, Sept. 28 — Safety experts for the Food and Drug Administration

urged the agency on Friday to consider an outright ban on over-the-counter,

multisymptom cough and cold medicines for children under 6.

 

The recommendation, in a 356-page safety review, is the strongest signal yet

that the agency may take strong action against the roughly 800 popular

medicines marketed in the United States under names like Toddler's Dimetapp,

Triaminic Infant and Little Colds.

 

The next step in the process is a meeting of outside experts on Oct. 18 and

19 to examine the medicines' safety and offer recommendations to the agency.

 

In the new safety review, the agency's experts suggested that all " infant "

cough and cold formulations be removed from the market, and that the

droppers, cups and syringes included with products for children be

standardized to reduce the risks of confusion and overdose.

 

The reviewers wrote that there is little evidence that these medicines are

effective in young children, and there are increasing fears that they may be

dangerous. From 1969 to 2006, at least 54 children died after taking

decongestants, and 69 died after taking antihistamines, the report said. And

it added that since adverse drug reactions are reported voluntarily and

fitfully, the numbers were likely to significantly understate the medicines'

true toll.

 

The Consumer Healthcare Products Association, an industry trade group that

has consistently defended the safety of pediatric cough and cold medicines,

recommended in its own 156-page safety review, also released on Friday, that

the F.D.A. consider mandatory warning labels saying that they should not be

used in children younger than 2. Many cough and cold medicines now advise

parents to " consult a physician " before use in such children.

 

The proposed warnings " are recommendations that we have brought forth, and

we look forward to having a thorough discussion with the F.D.A., " said

Virginia Cox, a spokeswoman for the trade group.

 

Despite the industry's recommendation, many companies — including such

giants as Johnson & Johnson — continue to sell cough and cold medicines with

" infant " in their titles and pictures of babies on their labels.

 

Mark Boston, a spokesman for a Johnson & Johnson subsidiary that sells

pediatric cough and cold medicines, said the company " supports the

materials " that the trade association submitted to the F.D.A., but declined

to say why the company continues to sell such products as Concentrated

Tylenol Infants' Drops Plus Cold.

 

Dr. Joshua Sharfstein, Baltimore's commissioner of health and an author of a

petition that led the F.D.A. to conduct its current review, cheered its new

report, saying it raised serious questions about why anyone would give cough

and cold medicines to young children.

 

" These products are used by hundreds of thousands of kids every year, but no

one can say that they're safe or effective, " he said.

 

The petition followed a study by the Centers for Disease Control and

Prevention that found that more than 1,500 children under the age of 2 had

suffered serious health problems between 2004 and 2005 after being treated

with common cough and cold medicines.

 

Current figures on the medicines' sales and use are not available, but in

1994 researchers reported in The Journal of the American Medical Association

that more than a third of all 3-year-olds in the United States were given

over-the-counter cough and cold preparations in one 30-day span.

 

The petition noted that in 1990, Americans spent nearly $2 billion on these

medications, and it said that in a typical drugstore, more than 30 separate

cough and cold preparations are marketed to parents for use in children.

 

Also on Friday, the F.D.A. warned the makers of nearly 200 unapproved

prescription medicines containing the pain-and-cough-relief drug hydrocodone

that by Oct. 31 they must stop making these products for children under 6.

 

Makers of all other unapproved hydrocodone products have until Dec. 31 to

stop making them.

 

Hydrocodone is a narcotic that is widely used to treat pain and suppress

cough. There are seven F.D.A.-approved prescription cough products

containing hydrocodone, and doctors can continue to write prescriptions for

those.

 

The agency's safety review and its decision to ban unapproved hydrocodone

products both result from gradual but significant changes in the standards

used for drug approvals.

 

In the case of pediatric over-the-counter medicines, the agency decided

decades ago that drug makers could market the medicines for children even

though they had only been tested in adults. Back then, it was assumed that

children's bodies were simply smaller versions of adult ones.

 

That assumption has proven untrue. Indeed, a growing number of studies

suggest that cough and cold medicines work no better in children than

placebos.

 

Despite this, there are 800 such products on the market and sales have long

been strong. Most major pharmacies carry a dozen or more brands. The

medicines are popular largely because children have an average of 6 to 10

colds each year, far more than adults.

 

Similarly, hydrocodone has never been shown to be safe and effective in

children, and its dangers as a powerful and potentially addictive narcotic

are clear. Even more broadly, 200 hydrocodone-containing products never won

approval from the modern-day F.D.A.

 

There are thousands of such unapproved drugs on the market. Indeed, an

estimated 2 percent of all prescriptions are written for unapproved

products. Most have been around for decades, and the F.D.A. is gradually

forcing their makers to either get official approval or stop selling them.

 

Copyright 2007 The New York Times Company

 

 

 

[Guest guest]

>

> WASHINGTON, Sept. 28 — Safety experts for the Food and Drug Administration

> urged the agency on Friday to consider an outright ban on over-the-counter,

> multisymptom cough and cold medicines for children under 6.

>

>

>

 

For the most part if a doctor is willing to give a child a cough

medicine instead of telling the parents to run a hot shower and stay in

the room with the child for a while, I'd be checking with a new doctor.

 

 

>

>

>

>