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Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A National Analysis of Data from 10-Year Post-marketing Surveillance

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Abstract

Introduction

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare, severe and potentially fatal cutaneous adverse drug reaction (the mortality rate is up to 10 %) associated with numerous and apparently heterogeneous drugs. The aetiology is unknown.

Objective

To report Italian cases of DRESS over a 10-year period.

Methods

We searched the National Pharmacovigilance Network (NPN) for the term ‘drug reaction with eosinophilia and systemic symptoms’ from 1 January 2004 to 1 January 2014, to identify all reports of DRESS. Each case was checked to avoid duplication.

Results

In the NPN, we identified 91 serious cases of DRESS: 68 were spontaneous, still-unpublished reports, while 23 additional cases were derived from screening of the scientific literature, performed by marketing authorization holders. Notably, the single common element linking all cases of DRESS was intake of a drug containing an aromatic ring.

Conclusion

Thanks to the largest national DRESS case series ever reported, we were able to hypothesize, for the first time, that there is an association between use of drugs containing an aromatic ring in their chemical structure and DRESS. This might aid understanding of the aetiology of DRESS and facilitate diagnosis.

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Acknowledgments

The authors thank Roberta Maj and Federico Masserini for their support in revising the manuscript.

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Correspondence to Giovanni Landoni.

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Funding

This work was supported by departmental funds only. The departments had no role in the design of the study; analysis and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication.

Conflict of interest

Francesca Renda, Giovanni Landoni, Renato Bertini Malgarini, Alessandro Assisi, Maria Luisa Azzolini, Marta Mucchetti, Giuseppe Pimpinella and Luca Pani have no conflicts of interest that are directly relevant to the content of this study.

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Renda, F., Landoni, G., Bertini Malgarini, R. et al. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A National Analysis of Data from 10-Year Post-marketing Surveillance. Drug Saf 38, 1211–1218 (2015). https://doi.org/10.1007/s40264-015-0343-3

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