Association between leukotriene receptor antagonist therapy and Churg-Strauss syndrome: an analysis of the FDA AERS database
- 1Medical Research Institute of New Zealand, Wellington, New Zealand
- 2Capital and Coast District Health Board, Wellington, New Zealand
- 3National Jewish Health, Denver, Colorado, USA
- Correspondence to Professor R Beasley, Medical Research Institute of New Zealand, P O Box 10055, Wellington 6143, New Zealand;
- Received 10 June 2009
- Accepted 1 November 2009
Background The possible role of leukotriene receptor antagonist (LTRA) therapy in the pathogenesis of Churg-Strauss syndrome (CSS) is uncertain. The aim was to examine the association between LTRA therapy and CSS in cases registered in the FDA Adverse Event Reporting System (AERS) database.
Methods All cases of suspected drug-induced CSS reported to the AERS database between November 1997 and April 2003 were reviewed. Subjects in whom LTRAs were the suspected medication and sufficient documentation existed to confirm the diagnosis of CSS were sequentially categorised into one of the following groups: (A) CSS before treatment initiation; (B) oral or inhaled corticosteroids reduced or stopped within 6 months of CSS onset; (C) possible prodromal phase of CSS at treatment initiation; (D) unstable asthma at treatment initiation; (E) stable asthma at treatment initiation.
Results There were 181 case reports of suspected drug-induced CSS with sufficient documentation to confirm a diagnosis of CSS; in 163 (90%) an LTRA was a suspect medication. In 140 of these 163 cases there was sufficient documentation to sequentially categorise the case into groups, with 13 (9%) in A, 27 (19%) in B, 11 (8%) in C, 28 (20%) in D and 61 (44%) in E.
Conclusion LTRA therapy was a suspect medication in most confirmed cases of CSS reported in the AERS database. In the majority of cases treated with an LTRA, CSS could not be explained by either corticosteroid withdrawal or pre-existing CSS. These findings are informative in considering the potential associations between LTRA therapy and CSS.
Supplementary data are published online only at http://thx.bmj.com/content/vol65/issue2
Funding Asthma and Respiratory Foundation of NZ, P O Box 1459, Wellington, New Zealand; Bowen Trust Board, P O Box 22117, Khandallah, Wellington, New Zealand.
Competing interests RB has received research grants and fees for consulting and/or speaking from AstraZeneca, GlaxoSmithKline and Novartis. HN has received research grants from Schering-Plough, Novartis, Genentech, Ception and AstraZeneca, fees for consulting from Genentech/Novartis, Abbot Laboratories, MediciNova, AstraZeneca, Amgen, GlaxoSmithKline, Schering-Plough, Dyson and Sepracor and is a member of the GlaxoSmithKline Speakers’ Bureau. RB and HN were co-authors in the previous publication of the association of asthma medication with CSS based on the FDA AERS database6 which was supported by GlaxoSmithKline. No pharmaceutical company had any involvement in the planning, design, analysis or interpretation of the current study. All other authors declare that they have no conflict of interest.
Provenance and peer review Not commissioned; externally peer reviewed.