According to a new study published in the March issue of Archives of Pediatrics and Adolescent Medicine, few medications are actually studied in children or specifically approved for that age group. Despite this, a continuing practice among the medical community allows these same adult medications to be prescribed to children "off-label."
Jump directly to: conventional view | alternative view | bottom line
What you need to know - Conventional View• Drug labeling is best defined as the guidance to doctors and other healthcare providers on how to use a drug.
• 78.7% of children hospitalized in the U.S. are given drugs which are off-label and approved only for adults.
• Off-label use accounted for $270 million (40.5%) of the total dollars spent on medications for hospitalized children, according to the FDA.
• The children most likely to receive drugs off-label have undergone surgery, are more than 28 days old, and suffer critical health conditions.
• In the absence of data, doctors use their medical judgment to decide on a particular drug and dose for children.
• A common practice among doctors is to use data from adults and adjust the dose according to a child's weight.
• Only 20-30% of drugs approved by the Food and Drug Administration are labeled for pediatric use.
• Medications approved for use on the central or autonomic nervous system, as well as nutrients and gastrointestinal medications, are most likely to be used off-label, according to the FDA.
• About 21% of total prescribed drug use is for conditions not indicated on the label, according to a 2001 U.S. government report.
• "We don't want to understudy children and we don't want to overstudy them. It's our job to get information that will help them and protect them at the same time," said Debbie Birenbaum, M.D., an FDA pediatric team leader.
What you need to know - Alternative ViewStatements and opinions by Mike Adams, author of Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them
• The fact that so many drugs never tested on children or approved for children are nonetheless being so widely prescribed for children is a glaring indictment of the so-called "evidence-based medicine" system defended by the FDA and drug companies.
• As this story clearly demonstrates, drugs are routinely prescribed to children regardless of whether there has been any safety testing conducted at all. This means U.S. children are essentially being used as human guinea pigs in large-scale uncontrolled medication experiments.
Bottom line• The majority of children hospitalized in the U.S. are given "adult-only" drugs that have never been tested on children.
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