Doctors can prescribe medications for off-label use, meaning that it is used in a manner not specified in the FDA-approved label or insert.Off-label prescribing is legal, with more than 20% percent of outpatient prescriptions written for off-label use.
FDA-approved drug labels contain information about the drug, including what conditions it is approved to treat, dosages, interactions with otherdrugs, side effects, and clinical studies on the product. However, the FDA regulates drug approval, not drug prescribing. This means that doctors are legally allowed to prescribe a drug for any reason they consider medically appropriate.
What are the benefits of prescribing medications for off-label use?
Off-label prescribing can benefit patients when all other FDA-approved medications have failed. The most common example iscancer.Cancertreatment often involves an off-label prescription of chemotherapy medications, since a chemotherapy drug approved for one type ofcancermay help treat other types of cancer.
Other circumstances in which off-label prescribing may occur includes:
- There is no current FDA-approved medication to treat the condition.
- You are unable to take the FDA-approved drug due to side effects or possible interactions with other medications.
- Drugs that the FDA has approved for a particular condition are too costly or unavailable in your area.
- Your doctor has enough evidence that a certain medication works well for a particular off-label condition.
What are examples of medications with off-label uses?
Doctors have prescribed off-label medications for many years. Below is a table that outlines some examples.
| Medication | Off-label use |
|---|---|
| Diphenhydramine | Chemotherapy-related emesis, insomnia |
| Azathioprine | Atopic dermatitis, pemphigus, psoriasis |
| Atenolol, metoprolol, propranolol | Prevention of migraine attacks |
| Beta-blockers | Social anxiety |
| Sildenafil | Sexual dysfunction symptoms in women |
| Fluoxetine | Diabetic neuropathy, fibromyalgia, hot flashes, premature ejaculation |
| Gabapentin | Restless leg syndrome |
What to ask your doctor about off-label medication use
If your doctor is considering using an FDA-approved drug for uses not mentioned on the label, you may consider asking them the following questions:
- For what conditions is the medication approved by the FDA?
- Are there other FDA-approved medications to treat my medical condition?
- What scientific studies support the use of this drug to treat my condition?
- What are the chances that this medication will work better than other approved treatments?
- What are the potential benefits and risks of treating my condition with this medication?
- Can I enroll in anyclinical trialsstudying the use of this drug for my condition?
- Will my health insurance cover treatment of my medical condition with this medication?
SLIDESHOW
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US Food and Drug Administration. Understanding Unapproved Use of Approved Drugs "Off Label." https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
Wittich CM, Burkle CM, Lanier WL. Ten common questions (and their answers) about off-label drug use. Mayo Clin Proc. 2012;87(10):982-990. doi:10.1016/j.mayocp.2012.04.017
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