Can doctors prescribe a drug to patients even if the FDA has not approved the drug for use in their condition?
Yes. Once a drug has been approved for one purpose physicians are free to prescribe it for any other purpose that – in their professional judgment – is both safe and effective. They are not limited to official, FDA-approved indications printed on the label. This “off-label” prescribing is done when medications have been found to be effective for new uses but have not had the formal (and often costly) applications and studies required by the FDA to formally approve the drug for these new indications. However, when physicians use a drug to treat a different indication there is usually extensive medical literature to support the off-label use. Erythropoietin and darbepoietin, for example, are commonly prescribed off-label for various types of anemia including anemia of chronic disease, anemia in the elderly, and postpartum anemia.
