Other safety alerts
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| Australia: Zinbryta (daclizumab): Product withdrawn after overseas reports of inflammatory brain disorders |
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The Therapeutic Goods Administration (TGA) advises consumers and health professionals that Biogen Australia, in consultation with the TGA, will withdraw Zinbryta (daclizumab) from the Australian market following cases of serious inflammatory brain disorders in Europe. The TGA has not received any reports of inflammatory brain disorders occurring in Australian patients who have been prescribed Zinbryta.
Cases of immune-mediated encephalitis and meningoencephalitis have been reported in overseas patients treated with Zinbryta. Given the nature and complexity of adverse events being reported around the world, Biogen Australia has stated that characterising the evolving benefit/risk profile of Zinbryta would not be possible with the limited number of patients being treated. Therefore, Biogen Australia considered it was in the best interest of patients to withdraw worldwide marketing authorisations for Zinbryta.
Given the impending withdrawal of Zinbryta in Australia, Biogen Australia has recommended the following:
- No new patients should start treatment with Zinbryta.
- Patients currently being treated with Zinbryta should be contacted immediately to discuss alternative treatment management plans.
- All patients discontinuing Zinbryta should be informed that adverse drug reactions may also occur up to six months after discontinuation and be advised to contact their physician immediately if any new symptoms such as prolonged fever, serious headache, nausea or vomiting occur.
- Be aware that other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis can occur.
- Patients stopping the product should be monitored at least monthly and more frequently as clinically indicated for up to six months after the last dose of Zinbryta.
- Be aware that product supply will cease by 31 May 2018.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/zinbryta-daclizumab
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA), and was posted on the Drug Office website on 3 Mar 2018, 8 Mar 2018 and 9 Mar 2018.
Ends/Friday, Mar 16, 2018
Issued at HKT 16:00
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