Drugs and medical devices obtain specific on-label indications for use by the Food and Drug Administration. Physicians are able to use such devices and drugs off label as part of the practice of medicine, but is this is good thing? This edition of In the Profession examines what it means to be off label in terms of regulations, clinical studies, industry marketing, and common areas of use.
US Food and Drug Administration, US Department of Health and Human Services.Off-label and investigational use of marketed drugs, biologics and medical devices. April 30, 2009. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm116355.htm.
2.
Serradell J., Galle B.Prescribing for unlabeled indications. HMO Practice. 1993;7(1):44-7.
Chen DT, Wynia MK, Moloney RM, Alexander GCU.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey. Pharmacoepidemiol Drug Saf. 2009;18(11):1094-1100.
5.
Milne CP, Bruss JBThe economics of pediatric formulation development for off-patent drugs. Clin Ther. 2008;30(11):2133-2145.
6.
Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder LS, Kauffman REDevelopmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157-1167.
7.
Amin SB, McDermott MP, Shamoo AEClinical trials of drugs used off-label in neonates: ethical issues and alternative study designs. Account Res. 2008;15:168-187.
8.
Winterfeld U. , Le Heuzey MF, Acquaviva E., Mouren MC, Brion F., Bourdon O.Off-label use of psychotropic medications in pediatric wards: a prospective study. Arch Pediatr.2009:16(9):1252-1260.
9.
Osuagwa LL, Korhonen MJ, Saano S., Heilin-Tanninen M., Naaranlahti T., Kokki H.Off-label and unlicensed drug prescribing in three pediatric wards in Finland and review of international literature. J Clin Pharm Ther . 2009;34:277-287.
10.
Rayburn WF, Farmer KCOff-label prescribing during pregnancy. Obstet Gynecol Clin North Am. 1997;24(3):471-478.
11.
Ratner M., Gura T.Off-label or off-limits? Nat Biotech. 2008 ;26(8):867-875.
12.
Leveque D.Off-label use of anti-cancer drugs. Lancet Oncol. 2008;9:1102-1107.
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Gillick MRControlling off-label medication use. Ann Intern Med. 2009;150:344-347.
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Joseph J., Deaton D., Eshan H., Bonanno M.Enforcement related to off-label marketing and use of drugs and devices: where have we been and where are we going?J Health Life Sci Law . 2009;2(2):73-108.
15.
Stafford RSRegulating off-label drug use- rethinking the role of the FDA. N Engl J Med. 2008;14(358):1427-1429.
16.
Ramos-Casals M., Soto MJ, Cuadrado MJ, Khamashta MARituximab in systemic lupus erythematosus: a systematic review of off label use in 188 cases. Lupus. 2009;18:767-776
17.
US Food and Drug Administration.FDA warning on quinine. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108799.htm.
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US Food and Drug Administration.Warning on using gabitril in patients without epilepsy. FDA Patient Safety News. 2005;39. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=319.
19.
Tabarrok A.From off-label prescribing towards a new FDA . Med Hypotheses. 2009;72:11-13.
