The incidence of pancytopenia in patients taking leflunomide alone or with methotrexate

Purpose To estimate the incidence of pancytopenia in patients taking leflunomide with or without methotrexate in Australia. Methods Review of spontaneous reports to the Australian Adverse Drug Reactions Advisory Committee (ADRAC); estimation of incidence using national prescription reimbursement dat...

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Bibliographic Details
Published in:Pharmacoepidemiology and drug safety 2007-01, Vol.16 (1), p.65-73
Main Authors: McEwen, John, Purcell, Patrick M., Hill, Richard L., Calcino, Lisa J., Riley, Cathy G.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Age Factors
Aged
Aged, 80 and over
Anemia - chemically induced
Anemia - epidemiology
Antirheumatic Agents - adverse effects
Antirheumatic Agents - therapeutic use
Australia - epidemiology
Carbamazepine - adverse effects
Carbamazepine - therapeutic use
Child
Drug Prescriptions - statistics & numerical data
Drug Therapy, Combination
drug utilisation
Drug Utilization Review - methods
Drug Utilization Review - statistics & numerical data
Female
Humans
Incidence
Isoxazoles - adverse effects
Isoxazoles - metabolism
Isoxazoles - therapeutic use
leflunomide
Male
Methotrexate - adverse effects
Methotrexate - therapeutic use
methotrexate adverse reaction reporting
Middle Aged
Neutropenia - chemically induced
Neutropenia - epidemiology
Organogold Compounds - administration & dosage
Organogold Compounds - adverse effects
pancytopenia
Pancytopenia - chemically induced
Pancytopenia - epidemiology
Thrombocytopenia - chemically induced
Thrombocytopenia - epidemiology
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Summary:Purpose To estimate the incidence of pancytopenia in patients taking leflunomide with or without methotrexate in Australia. Methods Review of spontaneous reports to the Australian Adverse Drug Reactions Advisory Committee (ADRAC); estimation of incidence using national prescription reimbursement data; concomitant exposure to methotrexate was estimated using three sources of information. Results ADRAC received 11 reports of pancytopenia (meeting predefined criteria) associated with the use of leflunomide during its first 31 months of marketing. In nine reports, the patients were also taking methotrexate. Estimates of incidence in patients taking leflunomide alone ranged from 1 in 3698 to 1 in 4582 patients exposed; for patients also taking methotrexate the estimates ranged from 1 in 575 to 1 in 822. Conclusions Use of methotrexate with leflunomide increases the risk of pancytopenia compared with use of leflunomide alone. The haematological toxicity of the combination requires further study. Copyright © 2006 Commonwealth of Australia, published by John Wiley & Sons, Ltd.
ISSN:1053-8569
1099-1557
DOI:10.1002/pds.1236