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

Marc Benderitter (1) , Francois Caire-Maurisier (2) , Caroline Crambes (2) , Thierry Pourcher (3) , Jean-Charles Martin (4) , Jacques Darcourt (5, 3) , Maâmar Souidi (6)

1 IRSN/PSE-SANTE - Pôle Santé Environnement - Direction Santé
2 PCA - Pharmacie Centrale des Armées (PCA), Direction des Approvisionnements en produits de Santé des Armées, Fleury-les-Aubrais, 45404, France
3 TIRO-MATOs UMR E4320 - Transporteurs et Imagerie, Radiothérapie en Oncologie et Mécanismes biologiques des Altérations du Tissu Osseux
4 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
5 CHU-Nice - Département de Médecine Nucléaire [Nice]
6 IRSN/PSE-SANTE/SESANE/LRTOX - Laboratoire de radiotoxicologie et radiobiologie expérimentale

Prophylaxis 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.

Mots clés: Potassium iodide; Thyroid; Nuclear accident; Iodine thyroid blocking; Potassium iodide Thyroid Nuclear accident Iodine thyroid blocking

Domaines: Biochimie, Biologie Moléculaire

Marc Benderitter, Francois Caire-Maurisier, Caroline Crambes, Thierry Pourcher, Jean-Charles Martin, et al.. Potassium iodide (KI) prophylaxis in the case of a nuclear accident: A new marketing authorization in France. Environmental Advances, 2022, 9, pp.100293. ⟨10.1016/j.envadv.2022.100293⟩. ⟨irsn-03953890⟩