Reactions 1500, p3 - 10 May 2014 Risk of interstitial pneumonia with rivaroxaban The Japanese Pharmaceuticals and Medical Devices Agency [PMDA] recently reviewed the occurrence of several cases of interstitial pneumonia, including fatal cases, after rivaroxaban treatment in the clinical practice setting. Rivaroxaban is indicated for the reduction of the risk of ischaemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The review by the PMDA showed that interstitial pneumonia resolved in patients who discontinued rivaroxaban treatment and initiated appropriate treatment (e.g. corticosteroids) at an early stage of the infection, whereas outcomes were fatal in some cases when rivaroxaban treatment was continued despite the occurrence of symptoms of interstitial pneumonia. As a result, the PMDA requested in February 2014 that an ’important precaution’ be added to the Japanese prescribing information for rivaroxaban relating to the potential risk of interstitial lung disease, and the signs and symptoms of the disease that patients should immediately report to their physician. Patients should also be carefully monitored by their physician for signs and symptoms of interstitial lung disease such as cough, bloody sputum or dyspnoea and, if symptoms are present, carry out measures such as chest X-rays, chest computer-tomography scans and/or serum marker tests. Rivaroxaban treatment should be discontinued if interstitial lung disease is suspected and appropriate measures for its treatment should be taken. Ministry of Health, Labour & Welfare. Rivaroxaban and Interstitial Pneumonia. Pharmaceuticals and Medical Devices Safety Information 310: 12-16, Feb 2014. Available from: URL: http://www.pmda.go.jp/english/service/pdf/precautions/ PMDSI-310.pdf 803102644 1 Reactions 10 May 2014 No. 1500 0114-9954/14/1500-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved

Risk of interstitial pneumonia with rivaroxaban

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Reactions 1500, p3 - 10 May 2014

Risk of interstitial pneumonia withrivaroxaban

The Japanese Pharmaceuticals and Medical DevicesAgency [PMDA] recently reviewed the occurrence ofseveral cases of interstitial pneumonia, including fatalcases, after rivaroxaban treatment in the clinical practicesetting. Rivaroxaban is indicated for the reduction of therisk of ischaemic stroke and systemic embolism inpatients with nonvalvular atrial fibrillation.

The review by the PMDA showed that interstitialpneumonia resolved in patients who discontinuedrivaroxaban treatment and initiated appropriatetreatment (e.g. corticosteroids) at an early stage of theinfection, whereas outcomes were fatal in some caseswhen rivaroxaban treatment was continued despite theoccurrence of symptoms of interstitial pneumonia. As aresult, the PMDA requested in February 2014 that an’important precaution’ be added to the Japaneseprescribing information for rivaroxaban relating to thepotential risk of interstitial lung disease, and the signsand symptoms of the disease that patients shouldimmediately report to their physician. Patients shouldalso be carefully monitored by their physician for signsand symptoms of interstitial lung disease such as cough,bloody sputum or dyspnoea and, if symptoms arepresent, carry out measures such as chest X-rays, chestcomputer-tomography scans and/or serum markertests. Rivaroxaban treatment should be discontinued ifinterstitial lung disease is suspected and appropriatemeasures for its treatment should be taken.Ministry of Health, Labour & Welfare. Rivaroxaban and Interstitial Pneumonia.Pharmaceuticals and Medical Devices Safety Information 310: 12-16, Feb 2014.Available from: URL: http://www.pmda.go.jp/english/service/pdf/precautions/PMDSI-310.pdf 803102644