Other safety alerts
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| Canada: ADEMPAS (riociguat) - New Contraindication for Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP) |
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Health Canada advised that patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) should not be treated with ADEMPAS. If any patients with PH-IIP are being treated with ADEMPAS, their treatment should be discontinued and their clinical status carefully monitored.
The RISE-IIP study, which was investigating the effects of ADEMPAS in patients with PH-IIP, has been terminated early due to an increased risk of mortality and serious adverse events among subjects with PH-IIP receiving ADEMPAS. PH-IIP is a rare condition where there is high blood pressure in the arteries of the lungs caused by a lung disease called idiopathic interstitial pneumonia (IIP).
ADEMPAS is not authorized in Canada for the treatment of PH-IIP. It is indicated in adult patients for the treatment of:
• inoperable chronic thromboembolic pulmonary hypertension
• persistent or recurrent chronic thromboembolic pulmonary hypertension after surgical treatment
• pulmonary arterial hypertension, as monotherapy or in combination with endothelin receptor antagonists
A contraindication in PH-IIP patients will be added to the Canadian Product Monograph for ADEMPAS following the early termination of the RISE-IIP clinical trial and based on preliminary data from the trial.
Healthcare professionals should not prescribe ADEMPAS for patients with PH-IIP. If any patients with PH-IIP are being treated with ADEMPAS their treatment should be discontinued and their clinical status carefully monitored.
The benefit-risk profile of ADEMPAS in its approved indications (inoperable and recurrent/persistent Chronic Thromboembolic Pulmonary Hypertension and Pulmonary Arterial Hypertension) remains favourable.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../59816a-eng.php
In Hong Kong, there are five registered pharmaceutical products containing riociguat, namely Adempas Tablets 0.5mg (HK-63505), 1mg (HK-63510), 1.5mg (HK-63511), 2mg (HK-63512) and 2.5mg (HK-63509). All these products are registered by Bayer Healthcare Ltd, and are prescription only medicines. Adempas is not approved for use in PH-IIP locally. Related news was previously reported by the EMA and MHRA, and was posted on the Drug Office website on 25 June and 9 August 2016 respectively. Letters to local healthcare professionals were issued on 27 June 2016. So far, the Department of Health has not received any adverse drug reaction report related to the products. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, August 16, 2016
Issued at HKT 13:00
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