FDA Panel Advises Against Use In Kids Younger Than Age 6 ... The panel, however, decided against making a similar recommendation for older children ... 6 to 11 years old, even though it had earlier agreed there was no evidence that the products do any good for that group, either.
No one knows how many children have had adverse reactions to the medications, but the federal Centers for Disease Control and Prevention reported earlier this year that at least 1,500 children younger than 2 suffered complications in 2004 and 2005. An FDA review prepared for the meeting described dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions, including at least 123 deaths.
So not, or questionably, effective for two years and younger and potentially decidedly dangerous; not, or questionably, effective for the six year olds and under ... but Americans buy about 95 million bottles of them a year, and there are more than 800 formulations in stores ... and Some experts say studies show the medications are only marginally effective in relieving symptoms in adults as well, but there is no evidence that adults face as significant risks from the products.
So it would appear FDA approval is more dependent on potential harmful effects and for those more vulnerable populations than that the product does what its stated beneficial effect proclaims ... There seems something(s) a little wrong with this.
Now, The FDA convened the hearing to evaluate doubts about the products' effectiveness and the mounting evidence that the medications can cause serious complications.The hearing was prompted by a petition filed by a group of health officials led by Joshua M. Sharfstein, Baltimore's health commissioner, after the deaths of four children in that area ... and The hearing came a week after major manufacturers of the medications voluntarily withdrew 14 products designed for children younger than 2, including well-known brands such as Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold and Robitussin Infant Cough DM Drops ... such anticpatory compliance would seem to indicate acknowledgement of the forthcoming information and decision.
So, Cold Remedies Are Unproven For Everyone.
The committee's recommendations also apply to antihistamines used to treat allergies ... and this is but the 'tip of iceberg' ... what of the use of risperidone in the under tens? A common enough practice here as with other of the psychotropics and often without FDA sanction for use for those age ranges.
Saturday, October 20, 2007
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