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

The term "off-label use" refers to prescribing medications for indications or uses that have not been specifically approved by the FDA. When a medication is developed, it undergoes rigorous evaluation, and its label will indicate the approved uses based on clinical trial data. However, healthcare providers may find that a medication can be beneficial for conditions other than those listed, based on emerging evidence and clinical experience.

This practice is common in medicine and can allow for greater flexibility in treatment, enabling clinicians to tailor therapies to their patients' needs. While it may lead to better patient outcomes in certain cases, it also requires healthcare professionals to carefully consider the risks and benefits, as there may be less research available on the safety and efficacy of the drug for the off-label indication.