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DOI: 10.1055/s-2007-976172
Adverse Effects of Drugs Used to Treat Hematologic Malignancies: Surveillance Efforts from the Research on Adverse Drug Events and Reports Project
Publication History
Publication Date:
24 May 2007 (online)
ABSTRACT
Pharmaceuticals used to treat hematologic malignancies can lead to unexpected adverse events that involve a wide range of organ systems and physiological processes. The National Cancer Institute and National Heart Lung and Blood Institute-funded Research on Adverse Drug Events and Reports (RADAR) project-a collaboration of the Robert H. Lurie Comprehensive Cancer Center, the Department of Veterans Affairs, the Northwestern University Feinberg School of Medicine, and numerous academic institutions-identifies and evaluates unexpected adverse drug reactions associated with drugs used to treat malignant disorders. This article reviews the features of the safety program maintained by the U.S. Food and Drug Administration and the RADAR program.
KEYWORDS
Adverse drug reactions - drug surveillance - hematologic malignancies - pharmaceutical safety
REFERENCES
- 1 Lazarou J, Pomeranz B H, Corey P N. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279(15) 1200-1205
- 2 Ladewski L A, Belknap S M, Nebeker J R et al.. Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: first results from the research on adverse drug events and reports project. J Clin Oncol. 2003; 21(20) 3859-3866
- 3 Lasser K E, Seger D L, Yu D T et al.. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med. 2006; 166(3) 338-344
- 4 Fast Track . Accelerated approval and priority review: accelerating availability of new drugs for patients with serious diseases. U.S. Food and Drug Administration. May 2006; http://www.fda.gov/oashi/fast.html#accelerated , Accessed November 27, 2006
- 5 Trontell A. Expecting the unexpected-drug safety, pharmacovigilance, and the prepared mind. N Engl J Med. 2004; 351(14) 1385-1387
- 6 Smalley W, Shatin D, Wysowski D K et al.. Contraindicated use of cisapride: impact of food and drug administration regulatory action. JAMA. 2000; 284(23) 3036-3039
- 7 Basser R L, O'Flaherty E, Green M et al.. Development of pancytopenia with neutralizing antibodies to thrombopoietin after multicycle chemotherapy supported by megakaryocyte growth and development factor. Blood. 2002; 99(7) 2599-2602
- 8 Graf G, Zaborski M, Quentmeier H, Drexler H G. Phorbol ester PMA induces expression of the thrombopoietin receptor MPL in leukemia cells. Leuk Lymphoma. 1996; 24(1-2) 149-157
- 9 Kessler D A. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA. 1993; 269(21) 2765-2768
- 10 Almenoff J, Tonning J M, Gould A L et al.. Perspectives on the use of data mining in pharmaco-vigilance. Drug Saf. 2005; 28(11) 981-1007
- 11 Sargent D J, Goldberg R M, Mahoney M R et al.. Rapid reporting and review of an increased incidence of a known adverse event. J Natl Cancer Inst. 2000; 92(12) 1011-1013
- 12 Soares H, Kumar A, Djulbegovic B. Quality of reporting of harms in NCI sponsored phase III hematological malignancies trials. Blood. 2005; 106 , (abst 292)
- 13 Bennett C L, Nebeker J R, Lyons E A et al.. The Research on Adverse Drug Events and Reports (RADAR) project. JAMA. 2005; 293(17) 2131-2140
- 14 Bennett C L, Luminari S, Nissenson A R et al.. Pure red-cell aplasia and epoetin therapy. N Engl J Med. 2004; 351(14) 1403-1408
- 15 Bennett C L, Connors J M, Carwile J M et al.. Thrombotic thrombocytopenic purpura associated with clopidogrel. N Engl J Med. 2000; 342(24) 1773-1777
- 16 Rajvanshi P, Shulman H M, Sievers E L, McDonald G B. Hepatic sinusoidal obstruction after gemtuzumab ozogamicin (Mylotarg) therapy. Blood. 2002; 99(7) 2310-2314
- 17 Wadleigh M, Richardson P G, Zahrieh D et al.. Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation. Blood. 2003; 102(5) 1578-1582
- 18 Cohen A D, Luger S M, Sickles C et al.. Gemtuzumab ozogamicin (Mylotarg) monotherapy for relapsed AML after hematopoietic stem cell transplant: efficacy and incidence of hepatic veno-occlusive disease. Bone Marrow Transplant. 2002; 30(1) 23-28
- 19 McKoy J M, Angelotta C, Bennett C L et al.. Gemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): an overview from the research on adverse drug events and reports (RADAR) project. Leuk Res. 2006 (September); 7 , (Epub ahead of print)
- 20 Bennett C L, Angelotta C, Yarnold P R et al.. Thalidomide- and lenalidomide-associated thromboembolism among patients with cancer. JAMA. 2006; 296(21) 2558-2560
- 21 Dimopoulos M, Spencer A, Atfal M et al. Study of lenalidomide plus dexamethasone versus dexamethasone alone in relapsed or refractory multiple myeloma (MM): results of a phase 3 study (MM-010). Blood. 2005; 106 , (abst 6)
- 22 Food and Drug Administration . Lenalidomide package insert. Available at: http://www.fda.gov/cder/foi/label/2006/021880s001.pdf , Accessed September 6, 2006
- 23 Food and Drug Administration . Thalidomide package insert. Available at: http://www.fda.gov/cder/foi/label/2006/021430s000,020785s031lbl.pdf , Accessed September 6, 2006
- 24 Bennett C L, Schumock G T, Desai A A et al.. Thalidomide-associated deep vein thrombosis and pulmonary embolism. Am J Med. 2002; 113(7) 603-606
- 25 Knight R, DeLap R J, Zeldis J B. Lenalidomide and venous thrombosis in multiple myeloma. N Engl J Med. 2006; 354(19) 2079-2080
- 26 Rajkumar S V, Blood E. Lenalidomide and venous thrombosis in multiple myeloma. N Engl J Med. 2006; 354(19) 2079-2080
- 27 Zonder J A, Barlogie B, Durie B G, McCoy J, Crowley J, Hussein M A. Thrombotic complications in patients with newly diagnosed multiple myeloma treated with lenalidomide and dexamethasone: benefit of aspirin prophylaxis. Blood. 2006; 108(1) 403 , (author reply 404)
- 28 Leyland-Jones B. Breast cancer trial with erythropoietin terminated unexpectedly. Lancet Oncol. 2003; 4(8) 459-460
- 29 Henke M, Laszig R, Rube C et al.. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet. 2003; 362(9392) 1255-1260
- 30 Lasser K E, Allen P D, Woolhandler S J, Himmelstein D U, Wolfe S M, Bor D H. Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002; 287(17) 2215-2220
- 31 Trontell A E. The RADAR project and the FDA. JAMA. 2005; 294(10) 1206 , (author reply 1206-1207)
- 32 Waxman H A. The lessons of Vioxx-drug safety and sales. N Engl J Med. 2005; 352(25) 2576-2578
Dr. Charles L Bennett
Northwestern University, 303 E. Chicago Avenue, Olson Pavilion
Suite 8250, Chicago, IL 60611
Email: cbenne@northwestern.edu