Health
France recalls rare disease drug Tavneos after deaths
AFP – news@thelocal.frPublished: 19 Aug, 2026 CET.Updated: Wed 19 Aug 2026 17:53 CET
A drug called Tavneos used to treat rare autoimmune diseases will be pulled from the shelves in France, the country’s medicine watchdog said Wednesday, after it was linked to 20 deaths in Japan
“The recall of all batches available in France will begin on August 19th,” France’s medicine safety agency ANSM said in a statement
The agency noted that the European Commission revoked the drug’s marketing authorisation earlier this month because “the benefits are no longer proven to outweigh its risks”
Tavneos is made by the US biotech firm Amgen and is sold by different partner pharmaceutical companies around the world
It is used to treat adults with severe and rare autoimmune diseases which cause inflammation of the blood vessels
Kissei Pharmaceutical, which sells the drug in Japan, said in May that 20 deaths had been reported among people using it since 2022
The company warned doctors of “the risk of severe liver dysfunction” and asked them to stop prescribing it
Both Kissei and Amgen said the deaths included cases for which no causal link to the medicine could be determined
But the warning raised doubts about the rigour of the study that was submitted to various regulatory authorities to determine whether it should be authorised for sale
The European Medicines Agency reassessed the data and recommended in July that the drug be stripped of its market authorisation
The European Commission endorsed that recommendation earlier this month
In France, the drug is prescribed to 600 patients, according to the ANSM
“Abruptly stopping Tavneos without switching to an alternative should be avoided to prevent the condition worsening,” the agency warned, advising patients to consult a doctor about alternatives
In the United States, the Food and Drug Administration offered Amgen the option of voluntarily withdrawing Tavneos from shelves
But the company refused, so a procedure is underway to determine whether they will be forced to pull the drug
Become a member or log in to continue reading
#Health
