Off-label use means using an FDA-approved drug to treat something other than what the drug was approved to treat. Basically, it refers to the unapproved use of an approved drug. This use might involve a different form of a drug or a different dose than initially approved.
Sometimes, physicians prescribe off-label medication use because patients have not seen success with other approved medications. Other times, doctors can recommend off-label use because an approved drug doesn’t exist for a particular condition, especially if the condition is considered rare.
Off-label use is not the same as experimental use. It doesn’t mean that the drug is being used in research trials. Off-label use is extremely common, and in some cases, off-label use becomes a standard of care for medical treatment.
Sometimes, drug manufacturers choose not to pursue the approval for off-label use of their products for other conditions because the FDA approval process is often lengthy and expensive.
On-label vs. Off-label
Generally, medical professionals are not required to disclose that they are prescribing medication for off-label use to patients.
Sometimes, patients worry that off-label drug or medication use is dangerous. However, this is a common and legal practice.