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When people hear the phrase “off-label use of medication”, it can sound confusing or even concerning. In simple terms, “off-label” means that a doctor prescribes a medication for a use that is not included in the official FDA approval of that medication. This does not mean the use is unsafe or experimental. In fact, off-label prescribing is often a vital and common part of medical care in the U.S.
The FDA’s role includes approval of the types of conditions that a drug can treat which corresponds to the advertising that the pharmaceutical company provides. However, the FDA does not review every possible medical benefit of a drug, every related medical condition, or every piece of new research. That is where medical providers come in. Doctors may consider scientific studies, drug class similarities, mechanisms of action (this is explained further below), and clinical experience when deciding whether a medication may help beyond its original approval.
