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Expert Opinion on Drug Safety Volume 12, 2013 - Issue 3
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Original Research

Impact of United States Food and Drug Administration's boxed warnings on adverse drug reactions reporting rates and risk mitigation for multiple myeloma drugs

Vishvas GargUniversity of New Mexico, College of Pharmacy, Pharmacoeconomics, Epidemiology, Public Policy, Outcomes Research program, 1 University of New Mexico, MSC 09 5360 Albuquerque, NM 87131, USA+1 910 777 4680; [email protected]
, MBA BPharm,
Dennis W RaischUniversity of New Mexico, College of Pharmacy, Albuquerque, NM, USA
,
June M McKoyNorthwestern University, Feinberg School of Medicine, Division of General Internal Medicine, Department of Medicine, Chicago, IL, USA;Northwestern University, Robert H Lurie Comprehensive Cancer Center, Chicago, IL, USA
,
Steven M TrifilioNorthwestern Memorial Hospital, Department of Pharmacy, Chicago, IL, USA
,
Jamiee HolbrookNorthwestern Memorial Hospital, Department of Pharmacy, Chicago, IL, USA
,
Beatrice J EdwardsNorthwestern University, Robert H Lurie Comprehensive Cancer Center, Chicago, IL, USA;Northwestern University, Department of Medicine and Orthopaedic Surgery, Chicago, IL, USA
,
Steven M BelknapNorthwestern University, Feinberg School of Medicine, Division of General Internal Medicine, Department of Medicine, Chicago, IL, USA
,
Athena T SamarasNorthwestern University, Feinberg School of Medicine, Department of Dermatology, Chicago, IL, USA
,
Beatrice NardoneNorthwestern University, Feinberg School of Medicine, Department of Dermatology, Chicago, IL, USA
&
Dennis P WestNorthwestern University, Robert H Lurie Comprehensive Cancer Center, Chicago, IL, USA;Northwestern University, Feinberg School of Medicine, Department of Dermatology, Chicago, IL, USA
 show all
Pages 299-307 | Published online: 12 Mar 2013

Citations (9)

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Read on this site (3)

Fabrizio Esma, Marco Salvini, Rossella Troia, Mario Boccadoro, Alessandra Larocca & Chiara Pautasso. (2017) Melphalan hydrochloride for the treatment of multiple myeloma. Expert Opinion on Pharmacotherapy 18:11, pages 1127-1136.
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Dennis W. Raisch, John A. Rafi, Cheng Chen & Charles L. Bennett. (2016) Detection of cases of progressive multifocal leukoencephalopathy associated with new biologicals and targeted cancer therapies from the FDA’s adverse event reporting system. Expert Opinion on Drug Safety 15:8, pages 1003-1011.
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Rasha M Arabyat, Dennis W Raisch, June M McKoy & Charles L Bennett. (2015) Fluoroquinolone-associated tendon-rupture: a summary of reports in the Food and Drug Administration’s adverse event reporting system. Expert Opinion on Drug Safety 14:11, pages 1653-1660.
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Articles from other publishers (6)

Mohamed Fizur Nagoor Meeran, Seenipandi Arunachalam, Sheikh Azimullah, Dhanya Saraswathiamma, Alia Albawardi, Saeeda Almarzooqi, Niraj Kumar Jha, Sandeep Subramanya, Rami Beiram & Shreesh Ojha. (2023) α-Bisabolol, a Dietary Sesquiterpene, Attenuates Doxorubicin-Induced Acute Cardiotoxicity in Rats by Inhibiting Cellular Signaling Pathways, Nrf2/Keap-1/HO-1, Akt/mTOR/GSK-3β, NF-κB/p38/MAPK, and NLRP3 Inflammasomes Regulating Oxidative Stress and Inflammatory Cascades. International Journal of Molecular Sciences 24:18, pages 14013.
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Eric P Borrelli & Conor G McGladrigan. (2020) Differences in safety profiles of newly approved medications for multiple myeloma in real-world settings versus randomized controlled trials. Journal of Oncology Pharmacy Practice 27:4, pages 887-896.
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Qing Shan, Xiaoyu Li, Mei Zheng, Xi Lin, Guotao Lu, Dongming Su & Xiang Lu. (2019) Protective effects of dimethyl itaconate in mice acute cardiotoxicity induced by doxorubicin. Biochemical and Biophysical Research Communications 517:3, pages 538-544.
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Thomas Goedecke, Daniel R. Morales, Alexandra Pacurariu & Xavier Kurz. (2018) Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations. British Journal of Clinical Pharmacology 84:3, pages 419-433.
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Keith B. Hoffman, Andrea R. Demakas, Mo Dimbil, Nicholas P. Tatonetti & Colin B. Erdman. (2014) Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS). Drug Safety 37:11, pages 971-980.
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Chieko Ishiguro, Yasushi Hinomura, Keiko Uemura & Tsutomu Matsuda. (2014) Analysis of the Factors Influencing the Spontaneous Reporting Frequency of Drug Safety Issues Addressed in the FDA’s Drug Safety Communications, Using FAERS Data. Pharmaceutical Medicine 28:1, pages 7-19.
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