The term 'off-label' refers to the practice of prescribing medications for purposes or to populations that are not specifically approved by regulatory authorities such as the U.S. Food and Drug Administration (FDA). While off-label use is legal and often common in medical practice, it can also carry increased risks for patients, as the safety and efficacy of the medication for these unapproved uses may not have been thoroughly evaluated. Physicians may resort to off-label prescribing based on clinical experience or emerging evidence.
Off-label meaning with examples
- A doctor prescribed gabapentin for chronic pain management, an off-label use, based on recent studies suggesting its effectiveness for conditions beyond epilepsy, which is its primary approved indication.
- In a mental health treatment setting, an antidepressant may be prescribed off-label to help reduce anxiety symptoms, even though the drug is officially licensed only for depression, demonstrating the flexible nature of psychiatric medication practices.
- An oncologist utilized a medication initially approved for breast cancer to treat a patient with a rare form of lymphoma, illustrating how off-label prescribing can sometimes provide new hope for patients when conventional treatments are not effective.
- During her pregnancy, a woman was given a medication off-label to manage severe nausea and vomiting, highlighting how off-label practices can provide necessary relief, despite concerns about potential risks to the fetus due to lack of extensive research.
- In pediatric patients, doctors frequently prescribe medications off-label, such as using certain antihypertensives to treat hypertension in children, where specific studies and formulations for young patients may be lacking.