Other safety alerts
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| Canada: Gilenya (fingolimod) is under review in light of serious adverse events including 11 deaths reported internationally with 4 involved heart-related events |
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Health Canada is informing Canadians of an ongoing safety review of the multiple sclerosis (MS) drug Gilenya (the brand name for fingolimod). The review was initiated following reports of serious adverse events, including 11 deaths reported internationally. No deaths have been reported in Canada. Currently, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role. Four of the 11 reports involved serious heart-related events (three involved heart attacks and one involved a disturbance of the heart rhythm), while the other seven are unexplained. Among these seven is a report involving a patient in the United States who died within 24 hours of taking the first dose. At the time of authorization, it was known that Gilenya can be associated with certain types of heart rhythm disturbances. The Canadian labelling contains several important warnings with respect to these risks. At this time, when the drug is used as recommended in the authorized Canadian drug label, the benefits of Gilenya are considered to outweigh the risks.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_28-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. The news has been released by the FDA and EMA and was posted on the website of Drug Office on 21 December 2011 and 21 January 2012 respectively.
Ends/ Tuesday, February 28, 2012
Issued at HKT 12:30 |
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