What Is an 'Off-Label' Drug?

Full Video Transcript

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. The term ”off label” means to use a drug for other reasons than what the FDA has approved the drug for. Off-label prescribing is not restricted by law and often is beneficial. A doctor can legally prescribe drugs for off-label purposes. Therefore, your doctor can prescribe any drug he or she thinks is most appropriate for your treatment. However, it is against the law for drug manufacturers to advertise or promote drugs for unapproved use or to alter information concerning off-label benefits of a medication. While some drugs have solid scientific evidence to support their off-label use, the majority of them do not.