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 ?
Getting insurance coverage for this off-label indication can be tough, but Dr.
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. (40) Patients with rare diseases--also called orphan diseases--are also often dependent on off-label uses for their treatment because the number of patients with each orphan disease is often too low to justify the tremendous expense associated with seeking FDA approval for those indications.
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.
This type of OLP is prescribing a medication for an indication other than those included on the FDA-approved label.The off-label indication may be a logical extension of an approved indication.
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).
hospitals from January 2000 to December 2008 concluded that 97 percent of the more than 18,000 in-hospital uses of Factor Vila were for off-label indications. (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.
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. It is noteworthy that, before the new regulation was enforced, thalidomide dispensing could only occur through aforementioned Ministry of Health programs and thus off label use was virtually impossible.
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. (37) According to a 2007 study, off-label uses also account for nearly 50% of cardiac medications and anticonvulsant drug prescriptions.
Oral antibiotics are an example, such as anti-inflammatory dose doxycycline (acne is 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.