I recently read that some drugs are used for “off-label” purposes. What does that mean?
A. “Off-label” use means that a drug is being used for a purpose not listed on the products’ label. This is common and acceptable practice by physicians, allowed by the Food and Drug Administration (FDA) for drugs the agency has already approved. The practice is also known as “new uses.” For example, the drug amitriptyline (am-i-TRIP-tuh-leen) is approved by the FDA as an antidepressant, but the drug is also sometimes prescribed “off-label” to treat migraine headaches or chronic pain. Off-label use is permitted because FDA approval of any drug is very comprehensive. Rigorous and thorough testing is required is required to help determine if a drug is safe and if it actually works for a designated disease or condition. Once that’s established and a drug is FDA-approved for a certain use, it’s not uncommon for research into the drug to continue. Along the way, scientists may discover that the drug can do something else useful beyond that for which it was approved — hence, an off-label or
