France Recalls Tavneos Drug After Japanese Fatalities

The drug Tavneos, used to treat rare autoimmune diseases, will be recalled in France starting August 19. This action follows a reported 20 deaths in Japan since 2022, linked to the medication. France's medicine safety agency, ANSM, confirmed the recall of all available batches.

Earlier this month, the European Commission revoked Tavneos' marketing authorization, citing that its benefits no longer outweigh its risks. The drug, manufactured by Amgen, is sold by partner companies globally and treats adults with severe autoimmune conditions causing blood vessel inflammation.

In Japan, Kissei Pharmaceutical, the drug's seller, warned doctors in May about the risk of severe liver dysfunction. While both Kissei and Amgen noted that a direct causal link to all reported deaths could not be determined, concerns have been raised regarding the initial study data submitted for authorization.

The European Medicines Agency recommended stripping the drug of its market authorization in July, a recommendation the European Commission endorsed. Around 600 patients in France are prescribed Tavneos, and the ANSM advises consulting a doctor for alternatives to avoid abrupt discontinuation.

In the United States, the FDA offered Amgen the option to voluntarily withdraw Tavneos, but the company refused. A procedure is currently underway to determine if a mandatory withdrawal will be enforced.