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Drugs: Off Label Use


"Off label" means that a drug has been approved by the FDA, but it is prescribed for a use that wasn't part of the FDA approval. Many drugs are prescribed "off label" based on current medical practices or the doctor's experience. 

How to find information about an off label use: 

Off-label drug use is only as good as the evidence on which it is based. Unbiased information about off-label drug use is not easy to find. An "off label" use is not likely to show up in the standard references.

The 2004 Consumer Drug Reference published by Consumer Reports has some information on off-label uses (available at offsite link or call 800.500.9760).

For information about how to conduct medical research, click here. For information about how to do medical research on the internet, click here.  For information about medical research services to do the searching for you, click here

Health insurance coverage for off label use: Even though the drug is FDA approved, your insurance carrier may bulk at paying for off label use. If it does, enlist the help of your doctor to gather the evidence to convince the insurance company of the medical necessity of the particular drug in your situation. To learn how to appeal a denial, click here.

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