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.
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. Kissei Pharmaceutical, which sells the drug in Japan, said in May that 20 deaths had been reported among people using the it since 2022. In France, the drug is prescribed to 600 patients, according to the ANSM.
“The recall of all batches available in France will begin on August 19,” France’s medicine safety agency ANSM said in a statement. Both Kissei and Amgen said the deaths included cases for which no causal link to the medicine could be determined. “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.
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”.
