{"id":6615,"date":"2019-11-18T10:00:38","date_gmt":"2019-11-18T15:00:38","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=6615"},"modified":"2026-03-22T19:25:54","modified_gmt":"2026-03-22T23:25:54","slug":"off-label-prescription-drugs","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/off-label-prescription-drugs\/","title":{"rendered":"Off-label prescription drugs: What you need to know"},"content":{"rendered":"

Years ago, when I was struggling with a mood disorder, my doctor prescribed a drug that is commonly used to treat seizures. I was confused. Why was my physician giving me a medication indicated for such a different condition? Was it a normal standard of care to try drugs for new uses? Is such use safe?<\/p>\n

Maybe it\u2019s happened to you: Your medical practice sends a prescription to your pharmacy, then you learn that the medication is typically used to treat a completely different condition than your symptoms. This is called off-label prescribing (also known as prescribing for \u201cunapproved use\u201d). But what does that really<\/em> mean?<\/p>\n

What are off-label medications?<\/h2>\n

When the Food and Drug Administration (FDA) evaluates a new drug, the pharmaceutical company seeking approval must submit scientific evidence\u2014such as the results of clinical trials\u2014that the drug is effective for its intended use. When a medication receives FDA approval (after the lengthy approval process), it is for treatment of that particular<\/em> medical condition, and that indication only. Any other use of drugs is off-label.<\/p>\n

Is off-label drug promotion legal?<\/h2>\n

When a pharmaceutical company begins to sell the drug, it can exclusively mention the condition the product is approved to treat. Off-label marketing<\/a>, or advertising drugs for uses that are unapproved, could leave a pharmaceutical company open to litigation. It\u2019s illegal.<\/p>\n

Are doctors allowed to prescribe off-label drugs?<\/h2>\n

When a doctor prescribes a medication for off-label drug use, that means he or she has prescribed the drug outside of its approved indications. It\u2019s legal in the United States, and common, for doctors to prescribe off-label. In fact, many patients don\u2019t even realize when a prescription falls outside its approved use.<\/p>\n

Sometimes, FDA-indications are specific to dosages or patient characteristics (such as sex), rather than just the medical issue itself. A good example of this is age group\u2014most clinical trials test medications on adults rather than minors, so prescribing these medications to younger patients technically falls under the umbrella of off-label, or unapproved, use.<\/p>\n

Why do doctors prescribe medication off-label?<\/h2>\n

It\u2019s important to know that just because a drug use is off-label, it doesn\u2019t mean it will be an ineffective treatment. The reason why prescription drugs are widely used off-label is a practical one, says Amber Cann, Pharm.D<\/a>, a board-certified pharmacist in Kentucky. \u201cThe process of getting a drug through the clinical trial process and approved by the FDA can take two decades, and is incredibly expensive,\u201d she explains. \u201cIt is usually not within the drug manufacturer’s interest to seek further indications once the drug is on the market.\u201d<\/p>\n

\u201cOccasionally, a drug maker will invest in an additional indication, so that they can specifically market the drug for that purpose,\u201d Dr. Cann says. For example, the antidepressant Paxil<\/a> (paroxetine<\/a>), was available for some time before the manufacturer, GlaxoSmithKline, sought additional label indications on the package insert for generalized anxiety disorder and obsessive-compulsive disorder.<\/p>\n

These updates are rare\u2014and when they do happen, they take time. \u201cIt can take years before labeling catches up with recent clinical data suggesting a drug may be efficacious for a specific problem,\u201d says Amarish Dave<\/a>, MD, a neurologist and associate medical director at Mercyhealth<\/a> in Illinois. \u201cIn those intervening years, using drugs off-label can provide patients with improved care.\u201d<\/p>\n

Questions to ask your doctor about off-label prescription use<\/h2>\n

If you are curious about off-label use\u2014or nervous about it\u2014it is well within your rights as a patient to ask questions. You might want to know:<\/p>\n