Medicine Drug Attention Unapproved Off Label Information Label Treat

In the United States, there are two types of medications: "over-the-counter" (OTC) drugs, which can be purchased easily in stores, and "prescription medications," which are available only with a doctor's "prescription" (a written note from a doctor allowing a patient to buy a medicine that has restricted availability, usually because it could be dangerous or addictive). Medications are labeled with "indications" (reasons for taking the medicine) and recommended "dosages" (the amount of medicine that should be taken, and how often). All of the text on the "label" (the information found on the container in which the medicine is sold) is developed and agreed to by the "pharmaceutical company" (the company that develops, manufactures, and sells the drug) and the Food and Drug Administration (FDA), and cannot be changed.

But sometimes people "disregard" (choose not to follow or pay attention to) the information on the label. Instead, they "alter" (change) the use of the drug in what is called "off-label use of medication," because they are using it in a way that is not described on the label. Off-label use could involve using the medicine to treat a medical condition that isn't included in the official indications. It could also mean using the medicine for an unapproved age group, with an unapproved dosage, or with an unapproved form of "administration" (how something is given to a patient).

For example, some "stimulants" (substances that make parts of the body move more quickly or make one feel more awake) are approved for treating attention deficit disorder (ADD; a condition that makes it difficult for children to concentrate) in children. Doctors often prescribe those same stimulants to treat attention difficulties in adults, even though those the drugs have not been approved for that use with adults.