France recalls rare disease drug Tavneos after deaths
A drug called Tavneos, used to treat rare autoimmune diseases, will be pulled from shelves in France, the country's medicine watchdog said Wednesday, after it was linked to 20 deaths in Japan.
France is recalling the rare disease drug Tavneos following 20 deaths reported in Japan, the country's medicine safety agency ANSM announced on Wednesday. The European Commission revoked Tavneos' marketing authorization earlier this month, stating that the benefits no longer outweigh the risks. Kissei Pharmaceutical, which sells Tavneos in Japan, warned doctors of the risk of severe liver dysfunction and advised stopping its use.
However, both Kissei and Amgen, the U.S. biotech firm that manufactures Tavneos, stated that some deaths could not be linked to the drug. The European Medicines Agency recommended in July that Tavneos be removed from the market, and the European Commission endorsed this recommendation. In France, Tavneos is prescribed to 600 patients, and ANSM advises patients to consult a doctor about alternative treatments rather than abruptly stopping the drug.
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