What does "off-label" use of a medication refer to?

"Off-label" use of a medication refers to using a medication for a purpose other than its approved indication. This means that while the medication has been formally approved by health authorities, such as the FDA, for a specific condition or set of conditions, it can also be prescribed by healthcare providers for different conditions based on professional judgment and clinical evidence.

This practice is relatively common in medicine. For example, a drug approved for treating one type of cancer may be prescribed by a doctor to treat another type of cancer if there is clinical evidence supporting its efficacy for that condition, even though it hasn’t undergone the formal approval process for that specific use. Such decisions are often guided by research, expert consensus, or accumulating clinical experiences.

It's important to note that while off-label prescribing is legal and sometimes necessary, it may involve additional risks since the indications for use have not been rigorously vetted by regulatory bodies in the same way as the approved uses.