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Drug Safety

Erschienen in:

01.05.2008 | Correspondence

TNF-α Inhibitors and Leukaemia: International Pharmacovigilance Reports

verfasst von: Ronald H. B. Meyboom, Kristina Star, Jenny Bate, Ruth Savage, I. Ralph Edwards

Erschienen in: Drug Safety | Ausgabe 5/2008

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Excerpt

Since the first report in 2003 of the development of leukaemia in a patient using etanercept,[1] three more observations regarding leukaemia in suspected connection with a tumour necrosis factor-α inhibitor (TNFI) have appeared in the literature: one of etanercept[2] and two concerning infliximab (together with reactivation of tuberculosis in one).[3,4] Because of the serious nature of leukaemia, we think it is important to provide information on relevant international spontaneous report data, which indicate that there is a need for further evaluation. The more so since current product information makes an indecisive reference to a possible link with lymphoma and other malignant diseases.[5] …

Bakland G, Nossent H. Acute myelogenous leukaemia following etanercept therapy [letter]. Rheumatology (Oxford) 2003; 42: 900–1CrossRef

Bachmeyer C, Thioliere B, Khosrotehrani K, et al. Acute myelogenous leukemia in a patient receiving etanercept for psoriasis. J Am Acad Dermatol 2007 Jan; 56(1): 169–70PubMedCrossRef

Alcain G, Andrade RJ, Queipo de Llano MP, et al. Acute leukemia after infliximab therapy. Am J Gastroenterol 2003; 98: 2577PubMed

Broussais F, Kawashima M, Marotte H, et al. Chronic myeloid leukaemia and tuberculosis in a patient with rheumatoid arthritis treated with infliximab Ann Rheum Dis 2005; 64: 509–10PubMedCrossRef

Summary of product characteristics for infliximab and etanercept. Electronic medicines compendium [online]. Available from URL: http://emc.medicines.org.uk/ [Accessed 2007 Mar23]

Olsson S. The role of the WHO programme on international drug monitoring in coordinating worldwide drug safety efforts. Drug Saf 1998; 19(1): 1–10PubMedCrossRef

Phase II randomized study of infliximab in patients with low-or intermediate-risk myelodysplastic syndromes [online]. Available from URL: http://www.cancer.gov/clinicaltrials/EORTC-06023. [Accessed 2007 Jun 12]

Steensma DP, Mesa RA, Li CY, et al. Etanercept, a soluble tumor necrosis factor receptor, palliates constitutional symptoms in patients with myelofibrosis with myeloid metaplasia: results of a pilot study. Blood 2002; 99: 2252–4PubMedCrossRef

Thomas E, Brewster DH, Black RJ, et al. Risk of malignancy among patients with rheumatic conditions. Int J Cancer 2000; 88: 497–502PubMedCrossRef

10.

Baecklund E, Iliadou A, Askling J, et al. Association of chronic inflammation, not its treatment, with increased lymphoma risk in rheumatoid arthritis. Arthritis Rheum 2006; 54: 692–701PubMedCrossRef

11.

Askling J, Fored CM, Baecklund E, et al. Haematopoietic malignancies in rheumatoid arthritis: lymphoma risk and characteristics after exposure to tumour necrosis factor antagonist. Ann Rheum Dis 2005; 64: 1414–20PubMedCrossRef

12.

Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA 2006; 295(19): 2275–85PubMedCrossRef

13.

Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006; 29: 385–96PubMedCrossRef

Titel: TNF-α Inhibitors and Leukaemia: International Pharmacovigilance Reports
verfasst von: Ronald H. B. Meyboom
Kristina Star
Jenny Bate
Ruth Savage
I. Ralph Edwards
Publikationsdatum: 01.05.2008
Verlag: Springer International Publishing
Erschienen in: Drug Safety / Ausgabe 5/2008
Print ISSN: 0114-5916
Elektronische ISSN: 1179-1942
DOI: https://doi.org/10.2165/00002018-200831050-00013

Springer Medizin

Excerpt

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