Suzan
LIF Adolescent
Member since 5/06 754 total posts
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Important for Parents to read, NY Times today......
This is from today's N.Y. Times:
September 29, 2007
Ban Sought on Cold Medicine for Very Young
By GARDINER HARRIS
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.
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