Ministry of Health, Labour and Welfare Measures against Contamination with Nitrosoamines in Drugs

Abstract

 In recent years, nitrosamines, which are carcinogens, have been detected in some sartan drugs, ranitidine, nizatidine, metformin, etc., in Japan and overseas. The possibility that nitrosamines may be present even in drugs other than those in which nitrosamines have been detected cannot be denied, and it is important to reduce the risk of contamination as much as possible. Therefore, the Ministry of Health, Labour and Welfare notified the marketing authorization holders to conduct self-inspection of risks of contamination with nitrosamines. After that, questions and answers, smoothly facilitating the self-inspection, was revised and the Carcinogenic Potency Categorization Approach (CPCA) for N-nitrosamines, which was introduced overseas, was also introduced in Japan. Furthermore, the cases of nitrosamine contamination of drugs in Japan and overseas were collected and organized, and items that should be provided from a toxicological perspective, such as carcinogenic risk assessment based on the CPCA, were considered in the Health and Labour Sciences Special Research Grant. As a result, risk communication guidelines were formulated that coordinate the categorization of contents to be provided to medical worker and methods of cooperation with related organizations. Along with making the established guidance known, we considered how to it to organize thoughts so that the health impact assessment results of nitrosamines can be promptly provided to medical facilities, prepare for the occurrence of future cases. We will continue to plan and implement administrative measures that will lead to the resolution of the issue of nitrosamine contamination of pharmaceuticals.