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Unexpected outcome (positive or negative) including adverse drug reactions
CASE REPORT
Pirfenidone-induced hyponatraemia: insight in mechanism, risk factor and management
  1. Leann Silhan1,
  2. Panagis Galiatsatos1,2,
  3. Justine Corwine1,
  4. Sonye Danoff1
  1. 1Division of Pulmonary and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
  2. 2Critical Care Medical Department, National Institutes of Health, Bethesda, Maryland, USA
  1. Correspondence to Dr Panagis Galiatsatos, panagis.galiatsatos{at}nih.gov

Summary

Pirfenidone was approved in October 2014 in the USA for the treatment of idiopathic pulmonary fibrosis. Although not included in the adverse events published in the CAPACITY-1 and CAPACITY-2 or ASCEND trials, hyponatraemia was reported in supplementary data with rate of 3.4% in the active therapy arm versus 0.3% in the placebo arm. We performed a retrospective analysis of patients who were initiated on pirfenidone or nintedanib for the treatment of pulmonary fibrosis at our centre. Of the 52 patients who were started on pirfenidone, three (5.8%) developed severe hyponatraemia. Of the 29 patients who were started on nintedanib, none developed hyponatraemia. Laboratory data suggested syndrome of inappropriate antidiuretic hormone secretion (SIADH) induced by pirfenidone and the medication was discontinued. Hyponatraemia is a possible significant adverse effect of pirfenidone, able to induce SIADH in patients taking the medication.

  • unwanted effects / adverse reactions
  • interstitial lung disease

https://doi.org/10.1136/bcr-2017-222734

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    Footnotes

    • Contributors LS and SD cared for the three patients in this case report. PG assisted with follow-up care of the patients and review of the literature for this manuscript preparation. JC was the pharmacist involved in reviewing medication adverse events. All authors contributed to putting together the manuscript and care for the patients.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Provenance and peer review Not commissioned; externally peer reviewed.