What are the recent changes the FDA made for children under 6 regarding colds?

    Published: 06-16-2009
    Views: 55,127
    Ronald Turner, MD of the University of Virginia explains the recent changes the FDA made for children under 6 regarding colds.

    Dr. Ronald Turner

    Ronald Turner, MD, is Professor of Pediatrics and Associate Dean for Clinical Research at the University of Virginia School of Medicine. Dr. Turner earned his MD degree from Southern Illinois University and did his training in Pediatrics and Pediatric Infectious Diseases at Columbus Children’s Hospital (Ohio State University) and the University of Virginia. He subsequently served in faculty positions at the University of Utah and the Medical University of South Carolina. In addition to his administrative role at the University of Virginia, Dr. Turner has clinical care and teaching responsibilities in General Pediatrics and Pediatric Infectious Diseases. His research interests are directed at the pathogenesis and treatment of viral respiratory infections.

    Host: What recent changes did the FDA makes for children under 6?

    Ronald Turner: For many years there has been a questions about the use of common cold therapies in children and the reason is that there was never any data collected in children that showed these treatments worked. So, for many years we have extrapolated results from studies done in adults, where we say, for instance, the antihistamines work in adults, therefore we assume that they work in children and so, that s been the way we have decided about the use of these medications in children.

    That seemed to be a reasonable approach, until recently there, it s been highlighted that there have been some deaths in children associated with the use of these common cold therapies. Now, most of the deaths appear to be due to misuse of the treatment. So, over dosing and that sort of thing, that I think the decision of the FDA simply reflects the fact that there appears to be some risk associated with using these treatments and we have don t good evidence that there is benefit and so, therefore they have recommended that they not be used.

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