In June 2018 EU authorities were notified that a Chinese API manufacturer has detected the presence of N-nitrosodimethylamine, NDMA, in batches of Valsartan. NDMA is known to be genotoxic and carcinogenic and is classified as a Class 2A carcinogen to humans. After a referral under Article 31 of Directive 2001/83/EC the CHMP assessed the impact of the presence of this impurity on the benefit-risk balance of valsartan-containing drug products and issued a recommendation whether the concerning marketing authorisations can still be maintained or should be suspended.
Meanwhile, different Nitrosamines (NDMA, NDEA and others) were detected in almost every drug product which contains a sartan derivative as an API. Marketing Authorisation Holders have been requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs.