off-label indication

off-la·bel in·di·ca·tion

(awf-lā'bĕl in'di-kā'shŭn)
Use of a medication for a purpose other than that approved by the U.S. Food and Drug Administration.

off-la·bel in·di·ca·tion

(awf-lā'bĕl in'di-kā'shŭn)
Use of a medication for a clinical purpose other than that approved by the U.S. Food and Drug Administration.
References in periodicals archive ?
Medicines and their respective therapeutic indications cited in lawsuits analyzed by the National Cancer Institute Jose Alencar Gomes da Silva, as referred in the list of essential medicines of the WHO and off-label indication.
General Accounting Office (39) ("GAO") found that one third of cancer drugs were off-label and that more than half of all cancer patients received at least one drug for an off-label indication.
Recently, the indications for cochlear implantation were expanded to include patients with SSD, although this is still considered an off-label indication by the federal Food and Drug Administration.
53) However, a subsequent 2011 study of this off-label indication determined that use of Factor Vila off-label for heart surgery or hemorrhagic stroke patients not only failed to improve survival, but actually increased the likelihood of thromboembolism, or a blood clot, in the heart or brain.
These sources, however, are limited by publication lag, and they may not adequately address whether an off-label indication is a sufficiently effective treatment (Laetz and Silberman, 1991; McKenna, 1990).
Overall, the new regulation made control on dispensing and prescription apparently more efficient and established rules to authorize thalidomide dispensing if it is prescribed for an off-label indication.
General Accounting Office (GAO, now known as the Government Accountability Office) found that one-third of the drugs prescribed for the treatment of cancer were off-label, and that more than half of all cancer patients received at least one drug for an off-label indication.
This is, however, an off-label indication in the view of the Food and Drug Administration, which has approved the use of inhaled steroids in COPD only for added bronchodilation in patients already on a long-acting [beta]-agonist.
Grimes cautioned that vitiligo is an off-label indication for tacrolimus, pointing out that very long-term studies have not yet been conducted.