Other safety alerts
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| The United Kingdom: Riociguat (Adempas): not for use in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias |
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The Medicines and Healthcare products Regulatory Agency (MHRA) advised that patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
Riociguat (Adempas) is authorised in the UK for use in patients with WHO Functional Class II–III inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgery, and in patients with WHO Functional Class II–III pulmonary arterial hypertension (PAH).
RISE-IIP was a randomised, double-blind, placebo-controlled, multicentre phase II trial to investigate the efficacy and safety of riociguat in 145 patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)—an unapproved indication. The primary endpoint was change in the 6-minute walking-distance test after 26 weeks of treatment.
The trial was terminated early on the basis of interim results that showed increased mortality and increased risk of serious adverse events in the riociguat group compared with the placebo group. Moreover, preliminary data indicated that riociguat did not provide a clinically significant benefit for these patients. At the time of the interim assessment leading to termination of the trial, 21 deaths had been observed: 17 patients assigned riociguat and 4 assigned placebo. Serious adverse events, which were mainly respiratory disease or lung infections, were also higher in the riociguat group than in the placebo group.
In light of these findings, product information for riociguat will be updated in the UK to contraindicate the use of riociguat in patients with PH-IIP. The benefits of riociguat in its approved indications continue to outweigh the risks.
Studies of riociguat in patients with PAH have mainly assessed forms related to idiopathic PAH, heritable PAH, and that associated with connective-tissue disease. Use of riociguat in other forms of PAH that have not been studied is not recommended
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/riociguat-adempas-not-for-use-in-patients-with-pulmonary-hypertension-associated-with-idiopathic-interstitial-pneumonias
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 was posted on the Drug Office website on 25 June 2016. 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 09, 2016
Issued at HKT 13:00
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