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  1. #1
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    Default Cold remedy makers pull infant cold medications over safety concerns

    TORONTO - Drug makers voluntarily pulled a range of cold medicines aimed at children under the age of two off the market in the United States on Thursday, and at least two Canadian companies have followed suit.

    In tandem, Health Canada issued a statement Thursday with recommendations for the appropriate use of non-prescription cough and cold products in children.

    "Life-threatening adverse events, including unintentional overdose, have been reported to Health Canada in association with the use of these products in children under two years of age," the statement said.

    Cough and cold products - including natural health products - should not be given to children under two years of age unless the caregiver has been instructed to do so by a health-care practitioner, the recommendations state.

    Even if a product is labelled for use in children under two, it's still preferable to discuss its use with a doctor, Health Canada said.

    There are more than 700 authorized non-prescription cough and cold products marketed in Canada, the department said, and it is in the process of determining if the labelling is sufficient to ensure that parents and prescribers have all the information they need to make informed decisions about use of the products.

    In the U.S., the cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic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.

    In Canada, McNeil Consumer Healthcare said it is voluntarily withdrawing Infants' Tylenol Cold Dye Free Drops, Benylin (R) for Infants Cough and Cold Oral Drops and Benylin (R) for Infants Stuffy Nose Oral Drops.

    And an official with Wyeth Consumer Healthcare Canada said two Dimetapp products are being pulled in this country too - oral infant cold drops (one with dye and one without) as well as oral infant and fever drops.

    "The stand here is that Wyeth Consumer Healthcare is no longer recommending the use of cough-cold products in children under two years of age, and we are voluntarily withdrawing our infant cough and cold medications in the Canadian market," said Dr. Walid Aldoori, medical director at the company, which has its Canadian headquarters in Mississauga, Ont.

    "We will communicate definitely to health professionals, consumers and we definitely communicated to Health Canada, so there's an entire process which is taking place now."

    The Health Canada statement issued Thursday also urges parents to take note of medicinal ingredients in products, particularly if they might be giving more than one product to a child. If two products are being given, the combined use could lead to an overdose.

    "Because cough and cold medications often contain multiple ingredients, it is advised not to give more than one cough and cold product to a child," it said.

    "There is no cure for the common cold. Children will usually recover from coughs and colds in time on their own. The common cold is a mild, viral infection that can be managed by rest, sufficient fluid intake and comfort measures."

    Late last month the U.S. Food and Drug Administration tentatively recommended adding the words "do not use in children under two years" to product labelling of cough and cold products. Government scientists also said there is little evidence that cold medicines actually work in younger children.

    FDA will formally consider revising labelling 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 multi-year 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 of Sharfstein and other Baltimore city officials, who reported 900 Maryland children under four overdosed on the products in 2004.
    ~ Annie ~
    Mom to 4 (B24, G23, G19, G9)

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  2. #2
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    I was just reading an article about this on MSN and I'm quite suprised Annie never not any comments to her post! I guess everyone just assumed the article spoke for itself.

    But I was a bit upset...I know that when my kids were babies, the decongestant properties of the infant cold medicines we used (usually Tylenol brand) definitely helped them.

    And then I read this part of the article, and realized it has nothing to do with the effectiveness of the medication:

    "The products were withdrawn after numerous reports of parents failing to follow the products'
    directions, resulting in overdoses and deaths. In some cases, either too much medication was given,
    it was given too often, or more than one cough and cold medicine containing the same active
    ingredient were used."

    Yay, another "for your own safety" decision based on the ineptitude of some parents!
    Please always show kindness in your posts as the person receiving it may need it more than you will ever know.

    SAHM to two boys, 13 and 7.

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