Other safety alerts
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| Canada: ZINBRYTA (daclizumab beta) - Voluntary Withdrawal in Canada due to Risk of Encephalitis |
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Health Canada is advising healthcare professionals involved in dispensing and administration of ZINBRYTA including multiple sclerosis (MS) specialists, neurologists, pharmacists, pharmacies, MS societies and MS patient support/advocacy groups that following reports of serious inflammatory brain disorders, including immune-mediated encephalitis and meningoencephalitis, the manufacturer has decided to voluntarily withdraw ZINBRYTA from the Canadian market. The withdrawal is to be completed by April 30, 2018.
All treating healthcare professionals are advised to immediately contact patients in their care who have been prescribed ZINBRYTA, and to initiate alternative treatment options as soon as medically appropriate. No new patients can be started on or be prescribed ZINBRYTA. Given ZINBRYTA’s potential for liver injury, patients discontinuing the product should have serum transaminase levels and total bilirubin levels monitored monthly, for 6 months after receiving their last dose of ZINBRYTA. Healthcare professionals should inform their patients that adverse drug reactions may also occur up to 6 months after discontinuation and to contact their physician immediately if any new symptoms such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting occur. ZINBRYTA will not be available through Health Canada’s Special Access Program.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../66214a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and The Therapeutic Goods Administration (TGA), and was posted on the Drug Office website on 3 Mar 2018, 8 Mar 2018, 9 Mar 2018 and 16 Mar 2018.
Ends/Saturday, March 17, 2018
Issued at HKT 12:00
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