Potassium iodide (KI) prophylaxis in the case of a nuclear accident: A new marketing authorization in France

International audienceProphylaxis by “KI 65 mg, breakable tablet” is a pharmacological countermeasure of radiological protection adapted for the prevention of thyroid cancer after exposure to radioactive iodine. A first modification of the marketing authorization of “KI 65 mg, breakable tablet” for repeated prophylaxis for adults and children above 12 years old was obtained in France in 2020. At this point in time it is recommended to exclude the repeated intake of “KI- 65 mg, breakable tablet” by pregnant and breastfeeding women and children below 12 years old, who should consequently be subjected to a priority evacuation from the contaminated zone. Regulatory toxicology studies are underway in order to support an upcoming proposal of modification of the marketing authorization of “KI- 65 mg, breakable tablet” for repeated prophylaxis for pregnant women and children below 12 years old