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Health Canada Health products

ADEMPAS (riociguat) - New Contraindication for Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP)

Issued August 15, 2016
Issue
The RISE-IIP study, which was evaluating efficacy and safety of ADEMPAS (riociguat) in patients with symptomatic PH-IIP, has been terminated early, because interim results of RISE-IIP showed an increased risk of mortality and serious adverse events among patients receiving ADEMPAS compared to those receiving placebo. The available data indicate that the use of ADEMPAS in patients with PH-IIP presents greater risks than benefits.
Hazard description
Product safety