Understanding Unapproved use of Approved Drugs “Off Label” | U.S. Food & Drug Administration - oneGRAVESvoice

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Understanding Unapproved use of Approved Drugs “Off Label” | U.S. Food & Drug Administration

key information

source: U.S. Food & Drug Administration

year: 2018


Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical condition?

It is important to know that before a drug can be approved, a company must submit clinical data and other information to FDA for review. The company must show that the drug is safe and effective for its intended uses. “Safe” does not mean that the drug has no side effects. Instead, it means the FDA has determined the benefits of using the drug for a particular use outweigh the potential risks.

When you are prescribed a drug for its approved use, you can be sure:

• That FDA has conducted a careful evaluation of its benefits and risks for that use. 

• The decision to use the drug is supported by strong scientific data.

• There is approved drug labeling for healthcare providers on how to use the drug safely and effectively for that use.


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