What does the term "off-label" use refer to?

The term "off-label" use specifically refers to the practice of prescribing medications for purposes other than those that have been officially approved by the Food and Drug Administration (FDA). This means that a healthcare provider may utilize a medication to treat a condition, in a manner, or for a population that is not included in the drug's labeled indications.

Although this is done based on the provider's clinical judgment and may be supported by existing medical literature, such use lacks the regulatory approval that comes with on-label indications. It is important to note that while off-label use can be common in practice, it should be undertaken with consideration and care, ensuring that there is sufficient evidence to support the safety and efficacy of the drug for the new intended use.

This understanding is essential for healthcare professionals as it highlights the distinction between approved drug usage and the flexibility allowed under medical practice, while also reminding them of the potential implications of prescribing medications off-label.