Some kid cold medicines pulled off market

[Guest guest]

WASHINGTON - Drug makers on Thursday voluntarily pulled

children's cold medicines off the market less than two weeks after the

government warned of potential health risks to infants.

Over-the-counter medications aimed at children under the age of two

are being removed from store shelves because of rare instances of

parents accidentally overdosing young children, a trade group that

represents over-the-counter drug makers said. The group said parents

should not use any medicines they have at home.

 

The Consumer Healthcare Products Association said last month it

agreed with government officials that use of the drugs should be

restricted, but had previously stopped short of pulling the products

from the market.

 

Cold medicines being withdrawn include: Johnson & amp; Johnson Pediacare Infant

Drops and Tylenol Concentrated Infants Drops, Wyeth's

Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & amp;ler Thin Strips and Prestige Brands Holdings' Little Colds

Decongestant Plus Cough.

 

CVS Caremark Corp.

said Thursday morning it would remove the affected products as well as

CVS-brand equivalents from store shelves. The pharmacy chain said

customers can return the products for a full refund.

 

Late last month the Food and Drug Administration

tentatively recommended adding the words & quot;do not use in children under

two years & quot; to products' labeling. Current labeling directs parents to

consult a doctor before administering the drugs to infants and toddlers.

 

The medicines come in tiny, droplet-size doses, but parents

occassionally do not consult or follow directions from physicians,

which can lead to accidental overdose.

 

FDA will formally consider revising labeling at a meeting scheduled for Oct.

18-19.

 

After reviewing reports of side effects over the last four decades,

FDA found 54 child fatalities from over-the-counter decongestant

medicines. The agency found 69 reports of children's deaths connected

with antihistamines, which are used to treat runny noses.

 

The Consumer Healthcare Products Association said it will conduct a

multiyear campaign to educate parents and physicians on safe use of

cold medicines. A spokeswoman for the group said it was too early to

rule out a return of the products to the market.

 

& quot;The manufacturers made this decision after a lot of consideration

and with great care for the best interests of parents and children, & quot;

said CHPA spokeswoman Virginia Cox. & quot;But we can't speak to what the

future holds. & quot;

 

The trade group stressed in a statement that the & quot;medicines are, and have

always been, safe at recommended doses. & quot;

 

However, industry critics challenged this statement.

 

& quot;When it comes to children under age two there are no recommended

doses on these products so it's not reasonable to claim they are safe

and effective when used as directed, & quot; said Dr. Joshua Sharfstein,

Baltimore's health commissioner.

 

FDA is reviewing the safety of cold medicines at the request

Sharfstein and other Baltimore city officials, who reported 900

Maryland children under four overdosed on the products in 2004.

 

Catherine Tom-Revzon, a pediatric pharmacist, said parents should

use natural therapies, including salt-water drops and humidifiers, to

treat young children's colds before using drugs.

 

& quot;These medications were never designed to cure colds but only to

treat cold symptoms, and in children under two there was little

evidence they were effective anyway, & quot; said Tom-Revzon, who is pharmacy

manager at the Children's Hospital at Mentefiore in New York City.

 

Shares of Johnson and Johnson rose 28 cents to $66.012 while shares of Wyeth

fell 12 cents to $46.02. Shares of Novartis AG rose 11 cents to $54.20 and

Prestige Brands Holdings Inc. fell 7 cents to $11.09.

 

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