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off-label
[ awf-ley-buhl, of‑ ]
adjective
- of, relating to, or denoting a drug prescribed for a particular indication even though the drug has not yet received approval from the Food and Drug Administration for that disease, condition, or symptom.
off label
adjective
- (of a prescription drug) relating to use, or being used, in ways for which it has not been approved
Example Sentences
If a patient has obesity or Type 2 diabetes and a substance use disorder, providers can and should start prescribing GLP-1 agonists “off-label” as a form of addiction treatment.
Although it has not been approved to treat mental health conditions, it is increasingly being used off-label to treat depression, suicidality and PTSD, said Dr. Brent Turnipseed, the medical director of a ketamine clinic Roots Behavioral Health in Austin, Texas.
Doctors can still prescribe ketamine for depression off-label, but insurance often won't cover drugs prescribed in ways the FDA hasn't approved.
"Offering an FDA-approved drug for off-label use could provide hope and improve both life expectancy and quality of life for these patients."
Meanwhile, medical experts are raising concerns, saying that there are not enough data about the effects of such weight loss drugs on those with lower BMIs and that the consequences of such off-label use remain largely unknown.
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