RESEARCH - The incidence of pancytopenia in patients taking Arava alone or with MTX

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Pharmacoepidemiol Drug Saf. 2007 Jan;16(1):65-73.

The incidence of pancytopenia in patients taking leflunomide alone or with

methotrexate.

Department of Executive Office, Therapeutic Goods Administration, Woden,

Australian Capital Territory, Australia.

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 Wiley &

Sons, Ltd.

PMID: 16634119

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=Abstra\

ctPlus & list_uids=16634119

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