Is The Use of Drugs Off-Label, an Unauthorized Abuse as Stated by FDA, or Is It a Professional Duty? "Comprehensive Review"
Corresponding Author(s) : Wafa Mahmoud Alshaiby
wafaalshaiby@gmail.com
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 2 (2023): 2023 Volume -11 - Issue 2
Abstract
In continuing medical education activities and medical journals, the phrase "off-label drug" (OLD) is widely used. Many healthcare professionals do not, however, fully understand what it is, how common it is, and what effects it has. Off-label drug use (OLDU) is the act of giving a patient a prescription for a condition that the medication has not been approved to treat. Every area of medicine is currently affected by OLDU, however it may be more common in specialties like pediatrics, pregnancy, or psychiatry where the patient population is less likely to take part in research studies. Pharmaceutical businesses are not allowed to promote their goods for a use other than that which is prescribed, which has led to numerous sizeable settlements for unlawful marketing. Doctors should only provide medications when they need them to lessen liability. Additionally, in order to assess the advantages and disadvantages and give their patients the best care possible, healthcare practitioners should educate themselves about OLDU. Our review's objective is to explain the significance and value of using prescription medications outside of their allowed use by outlining the advantages and hazards of doing so. Methodology: The review is based on information from prior research, investigations, and reviews of digital materials (websites, scholarly journals, Google search).
Keywords
Off-label drugs use
FDA regulations
ethics and legal consideration
1.
Wafa Mahmoud Alshaiby, Mabroukah Amr Ishrayhah, Einass Ragab Ibraheim. Is The Use of Drugs Off-Label, an Unauthorized Abuse as Stated by FDA, or Is It a Professional Duty? "Comprehensive Review". Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2023 Jun. 3 [cited 2026 Mar. 14];11(2):192-20. Available from: https://ijamscr.com/ijamscr/article/view/1326
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References
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29. Li D, Shi Y, Li M, Liu J, Feng X. Tranexamic acidcantreatultravioletradiation-inducedpigmentationinguineapigs. Eur J Dermatol. 2010;20(3):289-92. doi: 10.1684/ejd.2010.0912, PMID 20400389.
30. Li D, Shi Y, Li M, Liu J, Feng X. Tranexamic acidcantreatultravioletradiation-inducedpigmentationinguineapigs. Eur J Dermatol. 2010;20(3):289-92. doi: 10.1684/ejd.2010.0912, PMID 20400389.
31. Carone L, Oxberry SG, Twycross R, Charlesworth S, Mihalyo M, Wilcock A. Spironolactone. J Pain Symptom Manage.2017Feb;53(2):288-92. doi: 10.1016/j.jpainsymman.2016.12.320, PMID 28024992.
32. Vargas-Mora P, Morgado-Carrasco D.Spironolactoneindermatology: usesinacne, HidradenitisSuppurativa, femalepatternhairloss, andhirsutism. ActasDermo Sifiliogr. 2020;111(8):639-49. doi: 10.1016/j.adengl.2020.03.015.
33. Sachdeva S. Hirsutism: evaluationandtreatment. Indian J Dermatol.2010;55(1):3-7. doi: 10.4103/0019-5154.60342, PMID 20418968.
34. Ober KP, Hennessy JF. Spironolactonetherapyforhirsutismin A hyperandrogenicwoman. Ann Intern Med.1978Nov;89(5 Pt 1):643-4. doi: 10.7326/0003-4819-89-5-643, PMID 717935.
35. Cumming DC. Use ofspironolactoneintreatmentofhirsutism. Cleve Clin J Med.1990May;57(3):285-7. doi: 10.3949/ccjm.57.3.285, PMID 2357784.
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45. Kimball OP, Horan TN. The useofdilantininthetreatmentofepilepsy. Ann Intern Med.1939;13(5):787-93. doi: 10.7326/0003-4819-13-5-787.
46. Shapiro M. Acceleration ofgingivalwoundhealinginnon-epilepticpatientsreceivingdiphenylhydantoinsodium (dilantin, epanutin). Exp Med Surg.1958;16(1):41-53. PMID 13537920.
47. Goebel RW. Sodium diphenylhydantoinassociationwithoralhealing. J Oral Surg.1972;30(3):191-5. PMID 4501096.
48. Shafer WG, Beatty RE, Davis WB. Effect ofdilantinsodiumontensile strengthofhealingwounds. ProcSocExpBiol Med.1958;98(2):348-50. doi: 10.3181/00379727-98-24040, PMID 13554642.
49. Kolbert GS. Oral diphenylhydantoinincornealwoundhealingintherabbit. Am J Ophthalmol.1968;66(4):736-8. doi: 10.1016/0002-9394(68)91299-3, PMID 5729591.
50. Mcanally LE, Thompson D. Use ofphenytoinforwoundhealing. HospPharm.1992;27:649-50.
51. Talas G, Brown RA, McgroutherDA. Role ofphenytoininwoundhealing-A woundpharmacologyperspective. BiochemPharmacol.1999;57(10):1085-94. doi: 10.1016/s0006-2952(98)00363-3, PMID 11265677.
52. Anstead GM, Hart LM, Sunahara JF, Liter ME. Phenytoininwoundhealing. Ann Pharmacother.1996;30(7-8):768-75. doi: 10.1177/106002809603000712, PMID 8826558.
53. Lodha SC, Lohiya ML, Vyas MCR, SudhaBhandari GRR, Harsh MK. Role ofphenytoininhealinglargeabscesscavities. Br J Surg.1991;78:105-8.
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55. Wilde MI, Mctavish D. Tamsulosin. A reviewofitspharmacologicalpropertiesandtherapeuticpotentialinthemanagementofsymptomaticbenignprostatichyperplasia. Drugs. 1996Dec;52(6):883-98. doi: 10.2165/00003495-199652060-00012, PMID 8957159.
56. De Bruin D, Schieven LW, Van Der Wijk J, Van Driel MF. Priapisme na’off-label’-gebruikvantamsulosin [Priapism followingoff-labeluseof Tamulosin]. Ned Tijdschr Geneeskd.2008Nov8;152(45):2470-3. Dutch. PMID 19051800.
57. Meltzer Andrew C, Burrows Pamela K, Wolfson Allan B, Et Al.Effect oftamsulosinonpassageofsymptomaticureteralcolics. A randomizedclinicaltrial. JAMA Intern Med.2018;178:1051-7.
58. Al-Majed AA, Et Al.Propranolol. ProfilesDrug Subst Excipients RelatMethodol.2017;42:287-338.
59. Chiha M, Samarasinghe S, KabakerAS. Thyroidstorm: anupdatedreview. J Intensive Care Med.2015;30(3):131-40. doi: 10.1177/0885066613498053, PMID 23920160.
60. Brooks MH, Waldstein SS. Free thyroxineconcentrationsinthyroidstorm. Ann Intern Med.1980;93(5):694-7. doi: 10.7326/0003-4819-93-5-694, PMID 7212477.
61. Alshehri MM, Mudawi MME.Common drugswitheffectiveoff-labeluses.JPharmResInt. 2020:25-33. doi: 10.9734/Jpri/2020/V32i1030490.
62. Wittich CM, Burkle CM, Lanier WL. Ten commonquestions (andtheir answers) aboutoff-labeldruguse. Mayo ClinProc.2012;87(10):982-90. doi: 10.1016/j.mayocp.2012.04.017, PMID 22877654.
63. Promoting safetyofmedicinesforchildren. WHOlibrarycataloguing-Inpublication data. World Health Organization; 2007. Available from: Http://WwwWho.Int/Medicines/Publications/Essentialmedicines/Promotion_Safe_MedChildrens.Pdf.
64. Oberoi SS. Regulating off-labeldruguseinIndia: thearenaforconcern. PerspectClin Res.2015;6(3):129-33. doi: 10.4103/2229-3485.159935, PMID 26229747.
65. Frattarelli DA, Galinkin JL, Green TP, Johnson TD, Neville KA, Paul IMet al.Off-labeluseofdrugsinchildren. Pediatrics.2014;133(3):563-7. Available At: Http://Pediatrics. doi: 10.1542/peds.2013-4060, PMID 24567009.
66. Pandolfini C, Bonati M. A literaturereviewonoff-labeldruguseinchildren. Eur J Pediatr.2005;164(9):552-8. doi: 10.1007/s00431-005-1698-8, PMID 15912383.
67. Fairbairn BYD, Izzard C, Holtorf M.A comparativereviewofoff-labelpharmaceuticaluseandpromotioninEurope, The USandChina.JManag Care Pharm. 2011;5(1):2-4.
68. CarneiroAV, CostaJoao. Off-labelprescription: practiceandproblems. Rev Port Cardiol.2013;32(9):681-6. doi: 10.1016/j.repc.2013.01.006, PMID 23896300.
69. TewodrosEguale DL, Buckeridge AV, WinsladeNE, BenedettiA, HanleyJA, TamblynR.Association ofoff-labeldruguseandadversedrugeventsinanadultpopulation.JAMA InternMed. 2016;176(1, Jan).
70. TewodrosEguale DL, Buckeridge AV, WinsladeNE, BenedettiA, HanleyJA, TamblynR.Association ofoff-labeldruguseandadversedrugeventsinanadultpopulation.JAMA InternMed. 2016;176(1, Jan).
71. RockvilleMD. Off-labeldrugs: whatyouneedtoknow.AGency For Healthcare Research And Quality;2015.
72. BerryJ.What toknowaboutoff-labeldruguse.Med News Today. 2020.
73. Gota V, Divatia JV. Off-labeluseofdrugs: anevilor A necessity?Indian J Anaesth.2015Dec;59(12):767-8. doi: 10.4103/0019-5049.171555, PMID 26903667.
74. Fung A, Yue X, Wigle PR, Guo JJ. Off-labelmedicationuseinrarepediatricdiseasesintheUnited States. IntractableRare DisRes. 2021;10(4):238-45. doi: 10.5582/irdr.2021.01104, PMID 34877235.
75. Hunea I, Luca C, E?anu I, Hurmuzache M, Manciuc C, Dima I, Et Al.Ethical issuesregardingoff-labeladministrationofantibiotics. J IntercultManag Ethics.2020;3(1):29-38. doi: 10.35478/Jime.2020.1.04.
76. Levêque D.Off-labeluseofanticancerdrugs.Lancet Oncol. 2008;9(11):1102-7. doi: 10.1016/S1470-2045(08)70280-8, PMID 19012859.
77. guptask, nayakrp. off-label use of medicine: perspectiveof Physicians, Patients, Pharmaceutical Companies and Regulatory Authorities. J Pharmacol Pharmacother.2014Apr;5(2):88-92.
78. Lenk C, Duttge G. Ethical andlegalframeworkandregulationforoff-labeluse: European perspective. TherClin Risk Manag.2014Jul12;10:537-46. doi: 10.2147/TCRM.S40232, PMID 25050064.
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