Provider - Focused Strategies: Prescriber - FDA Labeling

Arif SA, Drury R, Ader P. Impact of Food and Drug Administration hepatotoxicity warning on prescribing and monitoring of dronedarone in a tertiary teaching hospital. Int J Pharm Pract. 2015;23(6):456-60.  Abstract

Bratsman A, Mathias K, Laubscher R, et al. Outpatient fluoroquinolone prescribing patterns before and after US FDA boxed warning. Pharmacoepidemiol Drug Saf. 11 May 2020. [Epub]  Abstract

Cowart K, Worley M, Rouby NE, Sando K. Evaluation of FDA boxed warning on prescribing patterns of fluoroquinolones for uncomplicated urinary tract infections. Ann Pharmacother. 2019;53(12):1192-9.  Abstract

Dabrowska A. (26 March 2018). “FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development” (PDF)

Do A, Noohi S, Elie D, et al. Health Canada warning on citalopram and escitalopram – its effects on prescribing in consultation-liaison psychiatry. Psychosomatics. 2016;57(1):57-63.  Abstract

FDA Amendments Act 2007. Wikipedia link

Heyward J, Olson L, Sharfstein JM, et al. Evaluation of the extended-release/long-acting opioid prescribing Risk Evaluation and Mitigation Strategy program by the US Food and Drug Administration: a review. JAMA Intern Med. 2019;180(2):301-9.  Abstract

Morkem R, Williamson T, Patten S, et al. Trends in antidepressant prescribing to children and adolescents in Canadian primary care: a time-series analysis. Pharmacoepidemiol Drug Saf. 2017;26(9):1093-9.  Abstract

Musleh S, Kraus S, Bennett K, Zaharan NL. Irish Medicines Board safety warnings: do they affect prescribing rates in primary care? Pharmacoepidemiol Drug Saf. 2011;20(9):979-86.  Abstract

[No authors listed] Chapter 6: Opioid Approval and Monitoring by the U.S. Food and Drug Administration In Phillips K, Ford MA, Bonnie RJ, eds. Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use. Washington, DC: Nation Academies Press (US): 2017.  Document

O’Brien PL, Cummings N, Mark TL. Off-Label prescribing of psychotropic medication, 2005-2013: an examination of potential influences. Psychiatr Serv. 2017;68(6):549-58.  Article

REMS program was formalized in 2007.   Wikipedia link

Research, Center for Drug Evaluation and Risk Evaluation and Mitigation Strategies (REMS) – Frequently Asked Questions (FAQs) about REMS. www.fda.gov  Accessed 5/21/20

Research, Center for Drug Evaluation and Risk Evaluation and Mitigation Strategies (REMS) – FDA’s Role in Managing Medication Risks. www.fda.gov  Accessed 5/21/20

Stanos S. Evolution of opioid risk management and review of the classwide REMS for extended-release / long-acting opioids. Phys Sportsmed. 2012;40(4):12-20.  Abstract

Winter JD, Reetz MR, Kerns JW, et al. Changes in asthma maintenance therapy prescribing patterns following the 2006 long-acting β-Agonist FDA drug warning. Clin Ther. 2017;39(4):697-701.  Abstract

Zhang V, Olfson M, King M. Opioid and benzodiazepine coprescribing in the United States before and after US Food and Drug Administration boxed warning. JAMA Psychiatry. 2019;76(11):1208-10.  Abstract