{"id":600142,"date":"2026-08-21T11:48:09","date_gmt":"2026-08-21T11:48:09","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/600142\/"},"modified":"2026-08-21T11:48:09","modified_gmt":"2026-08-21T11:48:09","slug":"tavneos-rare-disease-drug-recalled-in-republic-of-ireland","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/600142\/","title":{"rendered":"Tavneos: Rare disease drug recalled in Republic of Ireland"},"content":{"rendered":"<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">A drug used to treat rare autoimmune diseases has been recalled from shelves in the Republic of Ireland.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">Tavneos (Avacopan) is made by the US biotech firm Amgen and is sold by various partner pharmaceutical companies around the world.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">In May, Kissei, which owns the rights to the drug in Japan, reported 20 deaths from more than 8,500 patients who had been treated with it in the country since 2022.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">It is not clear if Tavneos was the direct cause of the deaths and Amgen has <a href=\"https:\/\/www.amgen.com\/newsroom\/company-statements\/amgen-statement-on-tavneos\" class=\"ssrcss-1e0jzsh-InlineLink e1kn3p7n0\" rel=\"nofollow noopener\" target=\"_blank\">previously said, external<\/a> &#8220;these figures include cases for which a causal relationship with the product could not be determined&#8221;.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">Tavneos is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">In July, the European Medicines Agency recommended that the drug be stripped of its market authorisation.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">The European Commission endorsed that recommendation earlier this month.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">The drug stopped being distributed from wholesalers in the Republic of Ireland on 11 August and the recall of any remaining stock at wholesale level was requested by the Health Products Regulatory Authority (HPRA) on Thursday.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">Irish broadcaster RT\u00c9 reports that before the European Medicines Agency&#8217;s recommendation, about 60 people were treated with Tavneos.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">The HPRA said the drug was only prescribed by consultants with &#8220;specialist experience in management of these conditions&#8221;, and added that some had already made the decision to take patients off this drug.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">The HPRA said patients currently taking the drug should not stop treatment without first consulting with their doctors.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">France&#8217;s medicine safety agency ANSM said the &#8220;recall of all batches&#8221; of the drug available in the country would begin on 19 August.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK said in June that it <a href=\"https:\/\/www.gov.uk\/government\/news\/mhra-review-of-the-benefits-and-risks-of-avacopan\" class=\"ssrcss-1e0jzsh-InlineLink e1kn3p7n0\" rel=\"nofollow noopener\" target=\"_blank\">was reviewing, external<\/a> the benefits and risks of the drug.<\/p>\n<p class=\"ssrcss-1q0x1qg-Paragraph e1jhz7w10\">The MHRA has been contacted for further comment.<\/p>\n","protected":false},"excerpt":{"rendered":"A drug used to treat rare autoimmune diseases has been recalled from shelves in the Republic of Ireland.&hellip;\n","protected":false},"author":2,"featured_media":600143,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[103,61,60,371],"class_list":["post-600142","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-ie","tag-ireland","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/600142","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=600142"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/600142\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/600143"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=600142"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=600142"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=600142"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}