• OFF LABEL USE OF PRESCRIPTION

  • Since the early 1960s, the Food and Drug Administration (FDA) has required that drugs used in the United States be both safe and effective. The label information on the container, in the package insert, in the Physicians’ Desk Reference (PDR), and in any advertising can indicate a drug’s use only in certain “approved” doses and routes of administration for a particular condition. The use of a drug for a disease not listed on the label, or in a dose, or by a route not listed on the label, is considered to be a “nonapproved” or “off-label” use of the drug. Physicians, based on their knowledge and on available current information, may use a drug for a use not indicated in the “approved” labeling if it seems reasonable or appropriate.

  • limited or no protection from stroke, increased risk of stroke, increased risk of bleeding, unforeseen Watchman complications