France Recalls Rare Disease Drug Tavneos Over Safety Concerns

France's medicine watchdog ANSM announced on Wednesday that it will recall all batches of Tavneos, a rare disease drug made by Amgen and sold by partner pharmaceutical companies worldwide. The decision comes after the European Commission revoked the drug's marketing authorization due to its risks outweighing its benefits.

The move is a result of 20 deaths reported in Japan since 2022 among patients using Tavneos, which is used to treat adults with severe and rare autoimmune diseases causing inflammation of the blood vessels. Kissei Pharmaceutical, the Japanese company selling the drug, warned doctors about 'the risk of severe liver dysfunction' and advised them to stop prescribing it.

France's ANSM has advised patients who are currently taking Tavneos to consult a doctor about alternative treatments to avoid worsening their condition. The agency is also warning that abruptly stopping the medication without switching to an alternative should be avoided.