Amitriptyline, amitriptyline/amitriptyline oxide, amitriptyline oxide: CMDh Scientific Findings and Basis for Changes, Amendments to Product Information and Implementation Schedule — PSUSA / 00010374/202101


Given the available data on interactions with duloxetine, childhood intoxication, and Brugada syndrome, PRAC considers the causal relationship between amitriptyline, amitriptyline/amitriptylinoxide, amitriptylinoxide and these risks at least a reasonable possibility. PRAC concluded that information about products containing amitriptyline, amitriptyline/amitriptylinoxide, and amitriptylinoxide should be changed accordingly. data source and details