Impact of united states food and drug administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs

Expert Opinion on Drug Safety

Volumn 12, Issue 3, 2013, Pages 299-307

  Garg, Vishvas ^a   Raisch, Dennis W ^a   McKoy, June M ^b,c   Trifilio, Steven M ^d   Holbrook, Jamiee ^d   Edwards, Beatrice J ^b,c   Belknap, Steven M ^b   Samaras, Athena T ^c   Nardone, Beatrice ^c   West, Dennis P ^c  

^a UNIVERSITY OF NEW MEXICO   (United States)

^b NORTHWESTERN UNIVERSITY   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d NORTHWESTERN MEMORIAL HOSPITAL   (United States)

Author keywords

Adverse drug reaction; Boxed warnings; Multiple myeloma; United States Food and Drug Administration

Indexed keywords

ANTINEOPLASTIC AGENT; BENDAMUSTINE; BORTEZOMIB; CARMUSTINE; CYCLOPHOSPHAMIDE; DOXORUBICIN; LENALIDOMIDE; MELPHALAN; THALIDOMIDE; VINCRISTINE;

ARTICLE; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CHROMOSOME ABERRATION; CONGESTIVE HEART FAILURE; DEATH; DRUG APPROVAL; DRUG HYPERSENSITIVITY; DRUG INDUCED CANCER; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEART LEFT VENTRICLE EJECTION FRACTION; HOSPITALIZATION; HUMAN; LEUKEMIA; LEUKOPENIA; LUNG TOXICITY; MULTIPLE MYELOMA; PATIENT EDUCATION; PRACTICE GUIDELINE; PRESCRIPTION; QUASI EXPERIMENTAL STUDY; RETROSPECTIVE STUDY; RISK FACTOR; SIDE EFFECT; THROMBOCYTOPENIA; VENOUS THROMBOEMBOLISM;

ANTINEOPLASTIC AGENTS; DRUG INFORMATION SERVICES; DRUG LABELING; DRUG TOXICITY; HUMANS; MULTIPLE MYELOMA; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84876572224     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2013.780024     Document Type: Article

References (42)

1. Lazarou J, Pomeranz B, Corey P. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279(15):1200-5 (Pubitemid 28193431)
2. Kohn L, Corrigan J, Donaldson M. To err is human: building a safer health system. National Academy Press, Washington DC; 2000
3. Davies E, Green C, Taylor S, et al. Adverse drug reactions in hospital inpatients: a prospective analysis of 3695 patient-episodes. PLoS One 2009;4(2):e4439
4. Thomsen LA, Winterstein AG, Sondergaard B, et al. Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Ann Pharmacother 2007;41(9):1411-26 (Pubitemid 47311361)
5. Karch AM. The gray areas of black box warnings. Am J Nurs 2006;106(6):77-8 (Pubitemid 43879661)
6. US Food and Drug Administration. Specific requirements on content and format of labeling for human prescription drug and biological products described in Sec. 21CFR20157: US government printing office via GPO access, 2010
7. Cook D, Gurugubelli R, Bero L. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings. Drug Saf 2009;32(11):1057-66
8. Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002;287(17):2215-20 (Pubitemid 34441937)
9. US Food and Drug Administration. Adverse event reporting system.
10. 2009. Available from: http://www.fda. gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm [Cited 03/October/2011]
11. US Food and Drug Administration. AERS reporting by healthcare providers and consumers by year.
12. http://www fda.gov/Drugs/GuidanceComplianceRegulatory Information/Surveillance/AdverseDrugEffects/ucm070456.htm [Cited 02/January/2013] 2011 Available from
13. O'Connor N. FDA boxed warnings: how to prescribe drugs safely. Am Fam Physician 2010;81(3):298-303
14. Katz LYMD, Kozyrskyj ALP, Prior HJM, et al. Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults. CMAJ 2008;178(8):1005-11
15. Kurian BT, Ray WA, Arbogast PG, et al. Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Arch Pediatr Adolesc Med 2007;161(7):690-6 (Pubitemid 47026329)
16. Nagar S, Mehta S, Bhatara V, Aparasu R. Health care consequences of black-box warnings for antidepressants in the United States and Canada. Res Social Adm Pharm 2010;6(1):78-84
17. Dorsey E, Rabbani A, Gallagher SA, et al. Impact of FDA black box advisory on antipsychotic medication use. Arch Intern Med 2010;170(1):96
18. Olfson M, Marcus SC, Druss BG. Effects of food and drug administration warnings on antidepressant use in a national sample. Arch Gen Psychiatry 2008;65(1):94-101
19. Dusetzina SB, Higashi AS, Dorsey E, et al. Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care 2012;50(6):466
20. Becker N. Epidemiology of multiple myeloma. Multiple Myeloma 2011;183:25-35
21. Siegel R, Ward E, Brawley O, Jemal A. Cancer statistics, 2011. CA Cancer J Clin 2011;61(4):212-36
22. Poulos AR, Gertz MA, Pankratz VS, Post-White J. Pain, mood disturbance, and quality of life in patients with multiple myeloma. Oncol Nurs Forum 2001;28(7):1163-71
23. Campbell DT, Stanley JC, Gage NL. Experimental and quasi-experimental designs for research. Houghton Mifflin, Boston; 1963
24. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology; multiple myeloma; 2012
25. US Food and Drug Administration. FDA approved drug products. Available from: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm fuseaction=Reports.ReportsMenu [Cited 03/October/2011]
26. PDR Network. Physicians Desk Reference. 20th to 63rd edition. Medical Economics Co, Montvale, NJ; 1966-2009
27. US Food and Drug Administration. What is a serious adverse event 2012. Available from: http://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm [Cited 2012 11/May/2012
28. David MF, June SA, William D. Empirical Bayesian data mining for discovering patterns in post-marketing drug safety. Proceedings of the ninth ACM SIGKDD international conference on Knowledge discovery and data mining ACM; Washington, DC; 2003
29. Robinson S, Pool R, Giffin RB. Emerging safety science: workshop summary. The National Academies, White Oak, MD; 2008
30. Evans SJW, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001;10(6):483-6 (Pubitemid 34100774)
31. Ricci J, Coulen C, Berger J, et al. Prescriber compliance with black box warnings in older adult patients. Am J Manag Care 2009;15(11):e103-e08
32. Horlen C, Malone R, Bryant B, et al. Frequency of inappropriate metformin prescriptions. JAMA 2002;287(19):2504-5
33. Lasser KE, Seger DL, Yu DT, et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med 2006;166(3):338-44
34. Marcus SC, Olfson M, Pincus HA, et al. Therapeutic drug monitoring of mood stabilizers in medicaid patients with bipolar disorder. Am J Psychiatry 1999;156(7):1014-18 (Pubitemid 29302792)
35. Nebeker J, Barach P, Samore MH. Clarifying adverse drug events: a clinician's guide to terminology, documentation, and reporting. Ann Intern Med 2004;140(10):795-801 (Pubitemid 38623529)
36. Olson M. Managing delegation in the FDA: reducing delay in the new-drug review. J Health Polit Policy Law 2004;29(3):397-430 (Pubitemid 38857506)
37. Center NVI. Investigative report on the vaccine adverse event reporting system. 512 Maple Ave. W. # 206. National Vaccine Information Center, Vienna, VA
38. US Food and Drug Administration. Prescribing information: Melphalan. In: editor. Services UDoHaH. Silver Spring, MD; 2011. Available from: http://www.accessdata.fda.gov/drugsatfda-docs/label/2011/014691s029lbl.pdf
39. Platt R, Carnahan RM, Brown JS, et al. The US food and drug administration's mini-sentinel program: status and direction. Pharmacoepidemiol Drug Saf 2012;21:1-8
40. Platt R, Wilson M, Chan KA, et al. The new sentinel network-improving the evidence of medical-product safety. N Engl J Med 2009;361(7):645-7
41. Behrman RE, Benner JS, Brown JS, et al. Developing the sentinel system-a national resource for evidence development. N Engl J Med 2011;364(6):498-9
42. US Food and Drug Administration. FDA Adverse Event Reporting System (FAERS). 2012. Available from: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Surveillance/AdverseDrugEffects/ default.htm [Cited 2012 02/February/2013]