Prescription drugs: What does 'off-label use' mean?

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Prescription drugs: What does 'off-label use' mean?


What does it mean when a drug is prescribed for an "off-label use"? Is this legal?



"Off-label use" means that a prescription drug is being prescribed for a purpose not listed on the product's label. This is a common and acceptable practice by doctors. When done under a doctor's care, off-label use of prescription drugs is legal and may be vital for optimal care in many disorders.

The Food and Drug Administration (FDA) allows off-label use for prescription drugs it has already approved for marketing. This is permitted because the FDA approval process for any new prescription drug is very comprehensive. Rigorous testing is required to determine if a drug is safe and if it actually works for the disease or condition for which it is approved.

The drug approval process is expensive and lengthy — often taking years for a drug to be thoroughly studied. For this reason, it is often not practical for the manufacturer to study more than a single use of a drug. This is why manufacturers typically market new medications for one specific condition.

After approval by the FDA, it is not uncommon for research on a drug to continue. Over time, doctors and scientists may find that the drug is useful for additional conditions. If such a use is discovered, but doesn't go through the FDA approval process, the drug's manufacturer is not allowed to advertise or promote the drug for the new use. But doctors and researchers are allowed to share such information with each other and the public.

Off-label use is up to a doctor's discretion. It is your doctor's responsibility to be well-informed about a drug before prescribing it for off-label use. This includes knowing about potential side effects and drug interactions. But it is also important to follow your doctor's instructions. Don't take larger doses or use the medication more often than prescribed. Report any side effects to your doctor.

Examples of off-label uses
Drug Labeled uses Off-label uses
Gabapentin (Neurontin) Seizures, postherpetic neuralgia Chronic pain, migraine prevention, hot flashes, tremor, hiccups
Metformin (Glucophage) Diabetes Polycystic ovarian syndrome
Fluoxetine (Prozac) Depression, PMS, obsessive-compulsive disorder, panic disorder Hot flashes, chronic pain, post-traumatic stress disorder, anxiety

Last Updated: 04/24/2006
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