Venous thromboembolism in myelodysplastic syndrome patients receiving lenalidomide: Results from postmarketing surveillance and data mining techniques

Clinical Drug Investigation

Volumn 29, Issue 3, 2009, Pages 161-171

  Yang, Xionghu ^a   Brandenburg, Nancy A ^a   Freeman, John ^a   Salomon, Maria Luisa ^a   Zeldis, Jerome B ^a   Knight, Robert D ^a   Bwire, Robert ^a  

^a CELGENE CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIANEMIC AGENT; HEPARIN; LENALIDOMIDE; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; RECOMBINANT ERYTHROPOIETIN; THALIDOMIDE; WARFARIN;

ADULT; AGED; ALGORITHM; ARTICLE; DATA BASE; DATA MINING; DEEP VEIN THROMBOSIS; DRUG DISTRIBUTION; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; FEMALE; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MYELODYSPLASTIC SYNDROME; POPULATION EXPOSURE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK FACTOR; RISK MANAGEMENT; UNITED STATES; VENOUS THROMBOEMBOLISM;

AGED; AGED, 80 AND OVER; ALGORITHMS; ANTINEOPLASTIC AGENTS; DATABASES, FACTUAL; ERYTHROPOIESIS; FEMALE; HUMANS; MALE; MIDDLE AGED; MYELODYSPLASTIC SYNDROMES; PRODUCT SURVEILLANCE, POSTMARKETING; PULMONARY EMBOLISM; RISK ASSESSMENT; THALIDOMIDE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VENOUS THROMBOEMBOLISM;

EID: 61349089755     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200929030-00003     Document Type: Article

References (39)

1. Shadduck RK, Latsko JM, Rossetti JM, et al. Recent advances in myelodysplastic syndromes. Exp Hematol 2007; 35 (4 Suppl. 1): 137-43
2. Catenacci DV, Schiller GJ. Myelodysplasic syndromes: a comprehensive review. Blood Rev 2005; 19 (6): 301-19
3. Ma X, Does M, Raza A, et al. Myelodysplastic syndromes: incidence and survival in the United States. Cancer 2007; 109 (8): 1536-42
4. Beyne-Rauzy O, Laurent G, Adoue D. Myelodysplastic syndromes in adults. Presse Med 2007; 36 (3 Pt 2): 481-91
5. Larson RA. Myelodysplasia: when to treat and how. Best Pract Res Clin Haematol 2006; 19 (2): 293-300
6. List A, Dewald G, Bennett J, et al. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 2006; 355 (14): 1456-65
7. Maier SK, Hammond JM. Role of lenalidomide in the treatment of multiple myeloma and myelodysplastic syndrome. Ann Pharmacother 2006; 40 (2): 286-9
8. Melchert M, Williams C, List A. Remitting activity of lenalidomide in treatment-induced myelodysplastic syndrome. Leukemia 2007; 21 (7): 1576-8
9. Melchert M, Kale V, List A. The role of lenalidomide in the treatment of patients with chromosome 5q deletion and other myelodysplastic syndromes. Curr Opin Hematol 2007; 14 (2): 123-9
10. Steurer M, Sudmeier I, Stauder R, et al. Thromboembolic events in patients with myelodysplastic syndrome receiving thalidomide in combination with darbepoietin-alpha. Br J Haematol 2003; 121 (1): 101-3
11. Cavo M, Zamagni E, Cellini C, et al. Deep-vein thrombosis in patients with multiple myeloma receiving first-line thalidomide-dexamethasone therapy. Blood 2002; 100 (6): 2272-3
12. Schutt P, Ebeling P, Buttkereit U, et al. Thalidomide in combination with vincristine, epirubicin and dexamethasone (VED) for previously untreated patients with multiple myeloma. Eur J Haematol 2005; 74 (1): 40-6
13. Miller KC, Padmanabhan S, Dimicelli L, et al. Prospective evaluation of low-dose warfarin for prevention of thalidomide associated venous thromboembolism. Leuk Lymphoma 2006; 47 (11): 2339-43
14. Zangari M, Barlogie B, Thertulien R, et al. Thalidomide and deep vein thrombosis in multiple myeloma: risk factors and effect on survival. Clin Lymphoma 2003; 4 (1): 32-5
15. Bennett CL, Schumock GT, Desai AA, et al. Thalidomide-associated deep vein thrombosis and pulmonary embolism. Am J Med 2002; 113 (7): 603-6
16. Bennett CL, Angelotta C, Yarnold PR, et al. Thalidomide-and lenalidomide-associated thromboembolism among patients with cancer. JAMA 2006; 296 (21): 2558-60
17. Bowcock SJ, Rassam SM, Ward SM, et al. Thromboembolism in patients on thalidomide for myeloma. Hematology 2002; 7 (1): 51-3
18. Hirsh J. Risk of thrombosis with lenalidomide and its prevention with aspirin. Chest 2007; 131 (1): 275-7
19. Hussein MA. Thromboembolism risk reduction in multiple myeloma patients treated with immunomodulatory drug combinations. Thromb Haemost 2006; 95 (6): 924-30
20. Rus C, Bazzan M, Palumbo A, et al. Thalidomide in front line treatment in multiple myeloma: serious risk of venous thromboembolism and evidence for thromboprophylaxis. J Thromb Haemost 2004; 2 (11): 2063-5
21. Baz R, Li L, Kottke-Marchant K, et al. The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma. Mayo Clin Proc 2005; 80 (12): 1568-74
22. Rajkumar SV. Thalidomide therapy and deep venous thrombosis in multiple myeloma. Mayo Clin Proc 2005; 80 (12): 1549-51
23. Menon SP, Rajkumar SV, Lacy M, et al. Thromboembolic events with lenalidomide-based therapy for multiple myeloma. Cancer 2008; 112 (7): 1522-8
24. Knight R, DeLap RJ, Zeldis JB. Lenalidomide and venous thrombosis in multiple myeloma. N Engl J Med 2006; 354 (19): 2079-80
25. Rajkumar SV, Jacobus S, Callander N, et al. A randomized trial of lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone in newly diagnosed multiple myeloma: a trial coordinated by the Eastern Cooperative Oncology Group. Blood 2007; 110: 13a
26. DuMouchel W, Smith ET, Beasley R, et al. Association of asthma therapy and Churg-Strauss syndrome: an analysis of postmarketing surveillance data. Clin Ther 2004; 26 (7): 1092-104
27. Diaz RL, Gardeazabal J, Manrique P, et al. Greater allergenicity of topical ketoprofen in contact dermatitis confirmed by use. Contact Dermatitis 2006; 54 (5): 239-43
28. Hauben M, Horn S, Reich L. Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions. Drug Saf 2007; 30 (2): 143-55
29. Hauben M, Patadia V, Gerrits C, et al. Data mining in pharmacovigilance: the need for a balanced perspective. Drug Saf 2005; 28 (10): 835-42
30. Hauben M, Madigan D, Gerrits CM, et al. The role of data mining in pharmacovigilance. Expert Opin Drug Saf 2005; 4 (5): 929-48
31. Heit JA. Cancer and venous thromboembolism: scope of the problem. Cancer Control 2005; 12 Suppl. 1: 5-10
32. Sgarabotto D, Prandoni P, Stefani PM, et al. Prevalence and patterns of symptomatic thromboembolism in oncohematology. Haematologica 1998; 83 (5): 442-6
33. Raza A, Meyer P, Dutt D, et al. Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes. Blood 2001; 98 (4): 958-65
34. Musto P, Falcone A, Sanpaolo G, et al. Thalidomide abolishes transfusion-dependence in selected patients with myelodysplastic syndromes. Haematologica 2002; 87 (8): 884-6
35. Strupp C, Germing U, Aivado M, et al. Thalidomide for the treatment of patients with myelodysplastic syndromes. Leukemia 2002; 16 (1): 1-6
36. Kurtin S, Sokol L. Practical considerations in the use of lenalidomide therapy for myelodysplastic syndromes. Cancer Control 2006; 13 Suppl.: 26-31
37. Bennett CL, Silver SM, Djulbegovic B, et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia. JAMA 2008; 299 (8): 914-24
38. O'Connell CL, Boswell WD, Duddalwar V, et al. Unsuspected pulmonary emboli in cancer patients: clinical correlates and relevance. J Clin Oncol 2006; 24 (30): 4928-32
39. Yang X, Freeman J, Bwire R. Data mining in pharmacovigilance practice: which algorithm to use? Drug Safety 2008; 31: 888 [abstract no. 1]