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The Physician's Desk Reference States That The Drug Prescribed To My Child "Isn't Approved For Use In Those Under Age 18". How Can The Physician Do This?

In the United States, any prescription medication that has Food and Drug Administration (FDA) approval, for any medical condition, can be prescribed for any other medical condition and to patients any age (with some exceptions). This prescription process is called "off-label" prescribing.

Most psychiatric and non-psychiatric medications prescribed to children fall in the "off label" category because it is very difficult to use children as research participants. If you have concerns about a drug that the doctor has prescribed to your child, you should discuss this issue with the doctor.

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Last Updated 04-June-2007
Document Source: http://www.education.wisc.edu/eptc/irc/pharm/006ph.html