Off-label use

The most extensive experience with tissue adhesive drug delivery exists in the fibrin sealant literature. This is clearly an off-label use of this agent as it is only currently approved for hemostasis in cardiac and splenic trauma surgery and for colon sealing at the time of colostomy closure. 

Adalimumab is a TNF-a inhibitor initially approved for the treatment of rheumatoid arthritis in 2003. It is approved for treatment of psoriatic arthritis and off-label uses and clinical... 

Another important consideration for treatment of cancers is reimbursement by third-party payors for off-label use of chemotherapy agents because of the high expense. The American Association of Cancer Centers (www.accc-cancer.org) provides... 

Very few injectable dosage forms have been specifically developed and approved by FDA for intraocular use. However, the ophthalmologist uses available parenteral dosage forms to deliver antiinfectives, corti-costerioids, and anesthetic products to achieve higher therapeutic concentrations intraocularly than can ordinarily be achieved by topical or systemic administration. These unapproved or off-label uses have developed over time as part of the physician s practice of medicine. However, these drugs are usually administered by subconjunctival or retrobulbar injection and rarely are they injected directly in the eye [301]. 

Epoetin alfa can be considered, especially if cardiovascular status is compromised, but the response can be impaired in patients with anemia of chronic disease (off-label use). The initial dosage is 50 to 100 units/kg three times weekly. If Hb does not increase after 6 to 8 weeks, the dosage can be increased to 150 units/kg three times weekly. 

Physicians are the prime recipients of this information, and their treatment of individual patients should be guided by it. (Guided is the correct word. The FDA cannot regulate individual physician practice. If information in the published literature supports use of a drug for conditions not described in the approved labeling, a physician has the right to prescribe for these off-label uses. One hopes there is evidence to support this indeed, medical professional societies often develop position papers when evidence becomes available to support such uses.)... 

Union, a 6 months extension of exclusivity may be granted if studies are performed demonstrating safety and efficacy in a paediatric population. In the European Union the problem of off-label use in paediatrics has been recognised by the Commission and a proposal is now in draft form to introduce new legislation in 2006. 

Authorises manufacturers of new drugs to disseminate information on unapproved (off-label) uses of approved products under very limited conditions. 

Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines consensus recommendations for evaluating appropriateness. Med JAust 2006 185 544-8. 

Thalidomide would fall into this category due to its inadequate testing but most commonly improper use refers to off-label use. Use of off-label pediatric medicines has been discussed earlier in this chapter. An example of off-label adult use is with Bromfenac (Duract), a nonsteroid anti-inflammatory drug. Duract was developed for short term therapy (<10 days) in 1997 butwith longer term, off-label, use elevated liver enzymes were evident and it was withdrawn approximately 1 year later. In its time on the market Duract generated approximately 90 million dollars in sales. 

Stanford University Medical Center (2008) 14 Dmgs identified as most urgendy needing study for off-label use. SdenceDaily http //www.science-daily.com/releases/2008/11/081124130939. htm. Accessed 17 Aug 2011... 

Horen B, Montastru JL, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label use in paediatric outpatients. Br J Clin Pharmacol 54 665-670... 

Off-label use to prevent influenza in family members of influenza pafienfs (N Engl J Med 2000 Nov 2 343( 18) 1282-1289) Affack rate reduced from 19% fo 4%... 

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