Other safety alerts
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| Canada: Gilenya (fingolimod) - Stronger recommendations regarding first-dose cardiovascular monitoring and use in patients with pre-existing cardiovascular conditions |
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Health Canada announced important new safety information on the multiple sclerosis drug Gilenya (fingolimod).
Isolated delayed-onset cardiovascular events, including transient asystole and unexplained death, have occurred within 24 hours of the first dose of Gilenya. Health Canada has completed its review, which included a number of international reports of deaths, several of which were considered possibly associated with Gilenya. No deaths have been reported in Canada. Fifty-four Canadian case reports of serious cardiovascular adverse events, possibly associated with Gilenya have been reported between March 09, 2011 and January 31, 2012. The majority of these cases have occurred within 6 hours of the first dose and consisted of bradycardia, hypertension, hypotension and dizziness/malaise/palpitations.
In response to these safety concerns, the Product Monograph for Gilenya has been updated in Canada to include the followings:
1. Initiation of Gilenya treatment results in reversible heart rate decrease and has also been associated with atrio-ventricular (AV) conduction delays and isolated cases of serious cardiovascular events and unexplained death.
2. An electrocardiogram (ECG) should be performed and blood pressure measured prior to and 6 hours after the first dose.
3. All patients should be monitored for signs and symptoms of bradyarrhythmia, with hourly pulse and blood pressure measurement for at least 6 hours after the first dose.
4. Gilenya should not be prescribed in patients with certain heart-related conditions or who take hear-rate lowering drug and extended monitoring beyond 6 hours is required in some circumstances. For details, please refer to the following link.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/../gilenya_hpc-cps-eng.php
In Hong Kong, Gilenya Hard Capsules 0.5mg (HK-61192), containing fingolimod, is registered by Novartis Pharmaceuticals (HK) Ltd. It is a prescription only medicine. Related news has been released by US FDA, EMA and Health Canada and was posted on the website of Drug Office on 21 December 2011, 21 January 2012, 28 February 2012, 21 April 2012 and 15 May 2012. A letter to inform healthcare professionals was issued on 23 April 2012. As reported on 21 April and 15 May 2012, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, August 24, 2012
Issued at HKT 12:30 |
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