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Drug-induced anaphylaxis: a decade review of reporting to the Portuguese Pharmacovigilance Authority

  • Pharmacoepidemiology and Prescription
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European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

Anaphylaxis is a potentially fatal systemic adverse drug reaction (ADR). It is an unpredictable and mostly dose-independent event that occurs suddenly following exposure to the causative drug. Our objective was to characterize a case series of anaphylactic reactions reported to the Portuguese Pharmacovigilance authority during the past decade. Patients’ demographic data and implicated drugs were analyzed as well as the severity of the ADR and time trends.

Methods

This study was a retrospective analysis of episodes of anaphylaxis, defined according to the Second Symposium on the Definition and Management of Anaphylaxis Criteria, reported to the Portuguese Pharmacovigilance System between 1 January 2000 and 1 November 2010

Results

Amongst the 16,157 ADR reported to the Portuguese Pharmacovigilance System during the 10-year study period, we found 918 (6 %) cases of anaphylaxis that met the proposed criteria. The age of the patients varied from 7 days to 91 years, with 87 cases (9 %) of anaphylaxis involving patients under 18 years of age. There was an overall female predominance (67 %), but the majority of pediatric patients were male (56 %). There was a trend toward increased reporting as the decade progressed, and 31 % (284) of all anaphylaxis cases were reported during the last 2 years of the study period. Of the anaphylaxis episodes reported, 19 % led to hospitalization and 24 (3 %) had a fatal outcome. Antibiotics were responsible for most cases (17 %) followed by nonsteroidal anti-inflammatory drugs/acetaminophen (13 %), antineoplastic/cytotoxic drugs and immune-modulators. Vaccines and radiographic contrast media were also important contributors to an anaphylactic event.

Conclusions

In this series of drug-related anaphylaxis, we found that most of the reported episodes were associated with widely used drugs, such as antibiotics and analgesics. Anaphylaxis can occur at any age. The female gender was more highly represented, with the exception of pediatric patients.

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Acknowledgments

The authors would like to thank the Portuguese Medicines Authority (INFARMED) for its collaboration in this study. The data presented in our work were provided by INFARMED, but were assessed without validation by INFARMED.

Conflict of interest statement

The author and co-authors have no conflict of interest.

Author information

Authors and Affiliations

  1. Northern Pharmacovigilance Centre, Faculty of Medicine, University of Porto, Rua Doutor Plácido da Costa, 4200-450, Porto, Portugal

    Inês Ribeiro-Vaz, Joana Marques & Jorge Polónia

  2. Faculty of Medicine of the University of Porto, CINTESIS—Center for Research in Health Technologies and Information Systems, Porto, Portugal

    Inês Ribeiro-Vaz & Joana Marques

  3. Allergy Unit, Département de Pneumologie, Hôpital Arnaud de Villeneuve, Montpellier, France

    Pascal Demoly

  4. Inserm U657, University Hospital of Montpellier, Montpellier, France

    Pascal Demoly

  5. ImmunoAlergology Department, Porto Hospitalar Centre, Porto, Portugal

    Eva Rebelo Gomes

Authors
  1. Inês Ribeiro-Vaz
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  2. Joana Marques
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  3. Pascal Demoly
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  4. Jorge Polónia
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  5. Eva Rebelo Gomes
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Corresponding author

Correspondence to Inês Ribeiro-Vaz.

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Author contributions

Inês Ribeiro-Vaz was responsible for most of the data collection and validation and also performed the statistical analysis. Joana Marques collaborated in data collection and validation. Pascal Demoly and Jorge Polónia supervised the writing of the paper. Eva Gomes conceptualized the revision and performed most of the literature review.

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Ribeiro-Vaz, I., Marques, J., Demoly, P. et al. Drug-induced anaphylaxis: a decade review of reporting to the Portuguese Pharmacovigilance Authority. Eur J Clin Pharmacol 69, 673–681 (2013). https://doi.org/10.1007/s00228-012-1376-5

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  • DOI: https://doi.org/10.1007/s00228-012-1376-5

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