France Recalls Rare Disease Drug Tavneos After Deaths
France will pull all Tavneos batches after 20 deaths were reported in Japan and regulators warned of severe liver dysfunction.
- On Wednesday, France's medicine watchdog ANSM announced Tavneos will be withdrawn from shelves after it was linked to 20 deaths in Japan, with recall of all batches beginning August 19.
- Safety concerns emerged after Kissei Pharmaceutical reported in May that 20 deaths had been reported among people using Tavneos since 2022, prompting the company to warn doctors of "the risk of severe liver dysfunction."
- Manufactured by US biotech firm Amgen, Tavneos treats rare autoimmune diseases causing blood vessel inflammation and was prescribed to 600 patients in France before withdrawal.
- ANSM cautioned patients against abruptly stopping Tavneos without consulting doctors about alternatives, while the US Food and Drug Administration offered Amgen the option to voluntarily withdraw the drug.
- The European Commission's decision reflects questions raised about the original approval process, as enforcement proceedings continue against Amgen after the company refused the European Medicines Agency's recommendation.
17 Articles
17 Articles
On 19 August, the National Drug Safety Agency launched a recall of all the lots available in France. The 600 patients following this treatment must consult their doctor and not stop alone.
Tavneos treatment, used for rare autoimmune diseases, is withdrawn from the French market after the report of deaths due to liver side effects Tavneos medicine, intended for
This Wednesday, the drug agency announces the withdrawal of Tavneos from the French market. The benefit/risk ratio has become unfavourable. This medication is used in the treatment of rare inflammatory diseases of the blood vessels.
The National Medicines Agency follows an opinion of the European health authorities, following the reporting of several deaths abroad.
Coverage Details
Bias Distribution
- 50% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
