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Even though the FDA approves medications for specific uses, a healthcare provider may prescribe a medication to treat a condition other than what it has been approved to treat by the FDA. This is called an "off-label" use. Because the best medication for your situation may be one that is used off-label, be sure to talk with your healthcare provider about the benefits and risks of using a medication off-label.

What Does "Off-Label" Mean?

In the United States, the Food and Drug Administration (FDA) approves medications for specific uses. If a medication is used for any other use (other than the approved uses), this is considered an "off-label" use. For instance, amitriptyline (Elavil®) is a prescription medication approved to treat depression. However, amitriptyline is commonly prescribed to also treat chronic nerve pain, even though it is not approved for this use. Using amitriptyline for pain is an "off-label" use.

Have Off-Label Uses Been Studied?

Many off-label uses of medications have been thoroughly studied. Just because a medication has been thoroughly studied for a specific use does not mean the FDA automatically approves it for this use. A drug company must apply to the FDA to have a new use for a medication approved. Because this process can be quite lengthy and expensive, many companies do not seek approval for off-label uses. If a medication is older (and generic versions are available), it often does not make sense financially to seek approval for off-label uses. However, if a medication is newer, a new use may mean a new patent for the medication (which may allow the drug company to keep the sole rights to market the medication for a longer period of time).

Off-Label Rules

Drug companies cannot advertise off-label uses for their medications. Similarly, there are special rules limiting how representatives of drug companies can discuss and promote off-label uses of medications. However, healthcare providers are not limited in prescribing medications off-label. There are no laws preventing the off-label prescribing of medications. In fact, the off-label use of medications can be very appropriate in many situations. On the other hand, the off-label use of medications can also be inappropriate. Using a medication off-label without scientific evidence to support such use (especially when other alternatives are available) is generally not appropriate.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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