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Some kid cold medicines pulled off market
By Matthew Perrone
Associated Press
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WASHINGTON, D.C. -- Drug makers on Thursday voluntarily pulled kids' cold medicines off the market less than two weeks after the government warned of potential health risks to infants.

Products aimed at children under the age of two are being removed from store shelves due to "rare instantances of misuse" that could lead to accidental overdose, a trade group that represents over-the-counter drug makers said.

Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & Toddler 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.

Late last month the Food and Drug Administration tentatively recommended adding the words "do not use in children under two years" to product labeling. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers. Government scientists also said there is little evidence that cold medicines actually work in younger children.

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, which represents drug makers, said it will conduct a multiyear campaign to educate parents and physicians on safe use of cold medicines.

The trade group stressed in a statement that the "medicines are, and have always been, safe at recommended doses."

However, industry critics challenged this statement.

"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," 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.

Shares of Johnson and Johnson rose 22 cents to $66.05 while shares of Wyeth fell 12 cents to $46.03. Shares of Novartis AG dipped one cent to $54.22 and Prestige Brands Holdings Inc. fell 6 cents to $11.10.

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Reader comments on this story - 4 total

Note: All views and opinions expressed in reader comments are solely those of the individual submitting the comment, and not those of the Pantagraph or its staff.

These are just... wrote on Oct 12, 2007 12:16 PM:

" another way for the gov't to get it's grip into you. You CANNOT ingest a PLANT that cures alot of the same ailments as these drugs, but you can pop yourself full of man made drugs(which are used to create worse drugs like Meth) as long as our politicians get a cut. LONG LIVE THESE FASCIST STATES OF AMERICA! "

.... wrote on Oct 11, 2007 8:52 PM:

" I do not give my babys over the counter meds when they are sick..and i dont take them either...alot of them are harming kids "

So sorry, NaNa wrote on Oct 11, 2007 2:04 PM:

" Words cannot express my feelings of sorrow on your family's loss. I'm sorry. "

NaNa wrote on Oct 11, 2007 1:04 PM:

" My Grandson died from Dextromethorphan Intoxication. It was listed as his cause of death. We followed the instructions on the label and consulted a physician. He was only four months old, the doctor advised us to give him one of these over the counter remedies. He died four days later, at first it was listed as SIDS. We pushed for extra testing that showed the Acetaminophen in the therapeutic range and the Dextromethorphan in the fatal range. How many children have died in their sleep from this medicine that were listed as SIDS? This product is made from OPIUM and 1 in 10 are unable to metabolize this ingredient, the only way to tell if your child is sensitive or not is they die. Now a blood test is available to look for a Chromo zonal variance, an enzyme that can tell you if your child is sensitive or not. Both of my granddaughters have been tested and both have this condition. I personally feel these products should be pulled from the counters and only administered after a blood test. "
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