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Off-Label Drug Use Linked to More Adverse Drugs Events (ADE)

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Off-label prescribing of drugs is common1,2 and has been identified as a potentially important contributor to preventable adverse drug events (ADEs). Significant deleterious effects can occur with off-label use of some drugs, such as cardiac valve damage with fenfluramine and phentermine (fen-phen),3 status epilepticus with tiagabine hydrochloride,4 thrombocytopenia with quinine sulfate,5 and thromboembolic events with recombinant factor VIIa. 6,7

Off-label drug use, and particularly off-label use without strong scientific evidence, is a risk factor for ADEs. Hence, physicians and physician organizations should recognize the enormity of the problem and be active participants in the promotion of cautious prescribing of drugs for off-label uses lacking strong scientific evidence.

Further reading

1. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians.Arch Intern Med. 2006;166(9):1021-1026.
2. Eguale T, Buckeridge DL, Winslade NE, Benedetti A, Hanley JA, Tamblyn R. Drug, patient, and physician characteristics associated with off-label prescribing in primary care.Arch Intern Med.2012; 172(10):781-788.
3. Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine.N Engl J Med.1997;337 (9):581-588.
4. Flowers CM, Racoosin JA, Kortepeter C. Seizure activity and off-label use of tiagabine.N Engl J Med.2006;354(7):773-774.
5. US Food and Drug Administration. FDA issues second warning against treating leg camp with quinine. Published July 8, 2010. Accessed September 28. 2015.
6. Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated factor VII in randomized clinical trials.N Engl J Med. 2010;363(19):1791-1800.
7. Avorn J, Kesselheim A. A hemorrhage of off-label use.Ann Intern Med. 2011;154(8):566-567.



Author: admin

menebar ilmu pengetahuan

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