France recalls Tavneos after deaths reported in Japan

France will recall all available batches of Tavneos, a drug used to treat severe rare autoimmune diseases, after safety concerns linked to deaths reported in Japan, the French medicine safety agency ANSM said Wednesday.

ANSM said the recall would begin on August 19. It said the European Commission had revoked the drug's marketing authorisation earlier this month because its benefits were no longer proven to outweigh its risks.

Tavneos is made by the US biotech firm Amgen and sold by partner pharmaceutical companies in different countries. It is used to treat adults with severe and rare autoimmune diseases that cause inflammation of blood vessels.

Kissei Pharmaceutical, which sells Tavneos in Japan, said in May that 20 deaths had been reported among people using the drug since 2022. The company warned doctors about the risk of severe liver dysfunction and asked them to stop prescribing it.

Kissei and Amgen said the reported deaths included cases where no causal link to the medicine could be determined.

The European Medicines Agency reassessed the data and recommended in July that Tavneos lose its market authorisation. The European Commission endorsed that recommendation earlier in August.

ANSM said Tavneos is prescribed to 600 patients in France. It warned patients not to stop taking it abruptly without switching to an alternative, saying they should consult a doctor.

In the United States, the Food and Drug Administration offered Amgen the option of voluntarily withdrawing Tavneos from shelves. Amgen refused, and a procedure is under way to determine whether the company will be forced to withdraw the drug.