Pneumonitis associated with leflunomide: a profile of New Zealand and Australian reports
Identifieur interne : 001C84 ( Main/Exploration ); précédent : 001C83; suivant : 001C85Pneumonitis associated with leflunomide: a profile of New Zealand and Australian reports
Auteurs : R. L. Savage [Australie, Nouvelle-Zélande] ; J. Highton [Australie] ; I. W. Boyd [Australie] ; P. Chapman [Australie]Source :
- Internal Medicine Journal [ 1444-0903 ] ; 2006-03.
Abstract
Background: Pneumonitis has very rarely been observed in patients taking leflunomide in clinical trials. Evidence is emerging that it is more frequent in clinical practice. Aim: The aim of this study was to investigate voluntary reports of suspected respiratory reactions to leflunomide held by the New Zealand Pharmacovigilance Centre (NZPhvC) and the Australian Adverse Drug Reactions Unit (ADRU) to ascertain if they fulfilled the criteria for pneumonitis and to define characteristics of this reaction. Method: Reports of respiratory adverse reactions attributed to leflunomide and received by the NZPhvC and the ADRU were analysed to identify those that were likely to be pneumonitis based on the criteria of Searles and McKendry. Features of these reports were examined to provide further information about this adverse reaction. Results: The NZPhvC and the ADRU received 14 reports considered to be pneumonitis occurring in patients taking leflunomide. Two case reports fulfilled the Searles and McKendry criteria for definite or probable hypersensitivity pneumonitis. The patients in the remaining reports had radiological evidence of pulmonary infiltrates, an acute respiratory illness and no evidence of precipitating infection. In two cases the patients were taking leflunomide alone; one improved when it was withdrawn. In the other 12 cases, patients were taking leflunomide in combination with methotrexate. In nine of these 12 patients pneumonitis occurred after leflunomide was added to methotrexate, usually within 12–20 weeks. One of the two patients who died had possible previous methotrexate pneumonitis. Leflunomide washout with cholestyramine was used to treat three patients, one with life‐threatening illness, with good results. Conclusion: This case series supports observations that leflunomide can cause pneumonitis either as monotherapy or in combination with methotrexate. The case histories indicate that prompt recognition is important to avoid life‐threatening disease and support the use of cholestyramine to remove leflunomide.
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DOI: 10.1111/j.1445-5994.2006.01035.x
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L." last="Savage">R. L. Savage</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>1 New Zealand Pharmacovigilance Centre, Department of Preventive and Social Medicine, and 2Department of Medicine, University of Otago Medical School, Dunedin, 4Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand and 3Adverse Drug Reactions Unit, Therapeutic Goods Administration, Canberra, Australian Capital Territory</wicri:regionArea><wicri:noRegion>Australian Capital Territory</wicri:noRegion></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Nouvelle-Zélande</country></affiliation></author><author><name sortKey="Highton, J" sort="Highton, J" uniqKey="Highton J" first="J." last="Highton">J. Highton</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>1 New Zealand Pharmacovigilance Centre, Department of Preventive and Social Medicine, and 2Department of Medicine, University of Otago Medical School, Dunedin, 4Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand and 3Adverse Drug Reactions Unit, Therapeutic Goods Administration, Canberra, Australian Capital Territory</wicri:regionArea><wicri:noRegion>Australian Capital Territory</wicri:noRegion></affiliation></author><author><name sortKey="Boyd, I W" sort="Boyd, I W" uniqKey="Boyd I" first="I. W." last="Boyd">I. W. Boyd</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>1 New Zealand Pharmacovigilance Centre, Department of Preventive and Social Medicine, and 2Department of Medicine, University of Otago Medical School, Dunedin, 4Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand and 3Adverse Drug Reactions Unit, Therapeutic Goods Administration, Canberra, Australian Capital Territory</wicri:regionArea><wicri:noRegion>Australian Capital Territory</wicri:noRegion></affiliation></author><author><name sortKey="Chapman, P" sort="Chapman, P" uniqKey="Chapman P" first="P." last="Chapman">P. Chapman</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>1 New Zealand Pharmacovigilance Centre, Department of Preventive and Social Medicine, and 2Department of Medicine, University of Otago Medical School, Dunedin, 4Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand and 3Adverse Drug Reactions Unit, Therapeutic Goods Administration, Canberra, Australian Capital Territory</wicri:regionArea><wicri:noRegion>Australian Capital Territory</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Internal Medicine Journal</title><title level="j" type="alt">INTERNAL MEDICINE JOURNAL</title><idno type="ISSN">1444-0903</idno><idno type="eISSN">1445-5994</idno><imprint><biblScope unit="vol">36</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="162">162</biblScope><biblScope unit="page" to="169">169</biblScope><biblScope unit="page-count">8</biblScope><publisher>Blackwell Publishing Asia</publisher><pubPlace>Melbourne, Australia</pubPlace><date type="published" when="2006-03">2006-03</date></imprint><idno type="ISSN">1444-0903</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1444-0903</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: Pneumonitis has very rarely been observed in patients taking leflunomide in clinical trials. Evidence is emerging that it is more frequent in clinical practice. Aim: The aim of this study was to investigate voluntary reports of suspected respiratory reactions to leflunomide held by the New Zealand Pharmacovigilance Centre (NZPhvC) and the Australian Adverse Drug Reactions Unit (ADRU) to ascertain if they fulfilled the criteria for pneumonitis and to define characteristics of this reaction. Method: Reports of respiratory adverse reactions attributed to leflunomide and received by the NZPhvC and the ADRU were analysed to identify those that were likely to be pneumonitis based on the criteria of Searles and McKendry. Features of these reports were examined to provide further information about this adverse reaction. Results: The NZPhvC and the ADRU received 14 reports considered to be pneumonitis occurring in patients taking leflunomide. Two case reports fulfilled the Searles and McKendry criteria for definite or probable hypersensitivity pneumonitis. The patients in the remaining reports had radiological evidence of pulmonary infiltrates, an acute respiratory illness and no evidence of precipitating infection. In two cases the patients were taking leflunomide alone; one improved when it was withdrawn. In the other 12 cases, patients were taking leflunomide in combination with methotrexate. In nine of these 12 patients pneumonitis occurred after leflunomide was added to methotrexate, usually within 12–20 weeks. One of the two patients who died had possible previous methotrexate pneumonitis. Leflunomide washout with cholestyramine was used to treat three patients, one with life‐threatening illness, with good results. Conclusion: This case series supports observations that leflunomide can cause pneumonitis either as monotherapy or in combination with methotrexate. The case histories indicate that prompt recognition is important to avoid life‐threatening disease and support the use of cholestyramine to remove leflunomide.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Nouvelle-Zélande</li></country></list><tree><country name="Australie"><noRegion><name sortKey="Savage, R L" sort="Savage, R L" uniqKey="Savage R" first="R. L." last="Savage">R. L. Savage</name></noRegion><name sortKey="Boyd, I W" sort="Boyd, I W" uniqKey="Boyd I" first="I. W." last="Boyd">I. W. Boyd</name><name sortKey="Chapman, P" sort="Chapman, P" uniqKey="Chapman P" first="P." last="Chapman">P. Chapman</name><name sortKey="Highton, J" sort="Highton, J" uniqKey="Highton J" first="J." last="Highton">J. Highton</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Savage, R L" sort="Savage, R L" uniqKey="Savage R" first="R. L." last="Savage">R. L. Savage</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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