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Simple English definitions for legal terms
off-label use
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A quick definition of off-label use:
Off-label use: When doctors use medicine or medical products in ways that are not approved by the government agency that checks if they are safe and effective. This means they are using them for conditions or situations that the medicine was not originally made for.
A more thorough explanation:
Off-label use refers to the use of prescription medicine or medical products for conditions and in circumstances not approved by the Food and Drug Administration (FDA).
For example, a medication that is approved by the FDA to treat depression may be prescribed by a doctor to treat chronic pain, which is not an approved use. Another example is the use of a medical device for a different purpose than it was originally intended.
Off-label use can be risky because the safety and effectiveness of the medication or product may not have been thoroughly tested for the specific use. However, in some cases, off-label use may be necessary when there are no other approved treatments available for a particular condition.
It is important to discuss any off-label use with a healthcare provider to fully understand the potential risks and benefits.