Rare disease drug Tavneos recalled in Republic of Ireland
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A drug used to treat rare autoimmune diseases has been recalled from shelves in the Republic of Ireland
Tavneos (Avacopan) is made by the US biotech firm Amgen and is sold by various partner pharmaceutical companies around the world
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
It is not clear if Tavneos was the direct cause of the deaths and Amgen has previously said “these figures include cases for which a causal relationship with the product could not be determined”
Tavneos is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels
In July, the European Medicines Agency recommended that the drug be stripped of its market authorisation
The European Commission endorsed that recommendation earlier this month
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
Irish broadcaster RTÉ reports that before the European Medicines Agency’s recommendation, about 60 people were treated with Tavneos
The HPRA said the drug was only prescribed by consultants with “specialist experience in management of these conditions”, and added that some had already made the decision to take patients off this drug
The HPRA said patients currently taking the drug should not stop treatment without first consulting with their doctors
France’s medicine safety agency ANSM said the “recall of all batches” of the drug available in the country would begin on 19 August
The Medicines and <a href="https://healthylife7.com/watch-mark-cuban-says-you-cant-fix-healthcare-until-every-price-is-known/” title=”Watch: Mark Cuban Says You Can’t Fix Healthcare Until Every Price Is Known”>Healthcare products Regulatory Agency (MHRA) in the UK said in June that it was reviewing the benefits and risks of the drug
The MHRA has been contacted for further comment
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