Dictionary

Off-label use refers to using a medication or medical device for a purpose other than what it has been approved for by regulatory agencies. This means that the medication or device has not been specifically tested or approved for the particular use or condition being treated but is being prescribed or used based on medical judgment and anecdotal evidence.

Off-label use is legal and common in medical practice, especially for treatments where there may be limited options or the approved options are ineffective. However, it may also carry potential risks and uncertainties as the safety and efficacy of the medication or device for off-label use may need to be better established.

In the context of addiction treatment, off-label use refers to the use of medications that have not been specifically approved by regulatory agencies for the treatment of substance use disorders (SUDs) but are prescribed based on medical judgment and anecdotal evidence. This may include the use of medications such as antipsychotics, anticonvulsants, and other types of drugs that have been approved for other medical conditions but have shown promise in the treatment of SUDs, such as alcoholism, opioid use disorder, and others. Off-label use of medications in addiction treatment is common and may provide additional options for patients who are not responding to approved treatments. However, the safety and efficacy of these medications for the treatment of SUDs may not be well established and may carry potential risks.