Off Label Use of Approved Drugs
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Off-Label Use of Approved Drugs
The drug label of FDA-approved drugs gives information about the drug, including the approved doses and how it’s to be given to treat the medical condition for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an “off-label” use. This can mean that the drug is:
Used for a different disease or medical condition.
Given in a different way (such as by a different route).
Given in a different dose.
For example, when a chemotherapy drug is approved for treating one type of cancer, but is used to treat a different cancer, it is off-label use.
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