[REVISION HISTORY]

Tavneos drug recall in Europe

Updated 1 time since CLSTR started tracking revisions of this situation.

What changed

2026-09-02 07:34 UTC → 2026-09-02 09:43 UTC · added ~~removed~~

The prescription drug Tavneos, used to treat rare autoimmune inflammatory vascular diseases, is being withdrawn from European markets following safety concerns. In August 2026, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced a recall after European health authorities cited a “risk-benefit ratio that has become unfavorable.” This decision followed reports from Japan, where the distributor Kissei reported approximately twenty deaths linked to severe liver complications. The situation raised questions regarding the integrity of the clinical studies used for the drug’s initial approval. By September 2026, the European Commission moved to withdraw the product’s marketing authorization across the entire European Union. Consequently, the Hungarian National Public Health and Pharmaceutical Center (NNGYK) ordered an immediate recall of all ~~batches.~~ batches from pharmacies and hospitals. The medication is specifically used for adults with granulomatosis with polyangiitis and microscopic polyangiitis. Investigations by the European Medicines Agency (EMA) identified risks of liver damage and vanishing bile duct syndrome, a rare and potentially fatal condition. Authorities also noted that irregularities in previous clinical tests rendered the data unreliable for guaranteeing safety and effectiveness. Medical professionals have advised patients not to stop treatment abruptly but to consult physicians to arrange a safe transition to alternative therapies.

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