The EU Response to the Presence of Nitrosamine Impurities in Medicines

The unexpected detection of nitrosamine impurities in human medicines has recently seen global regulators act to understand the risks of these contaminations to patients and to limit their presence. Over 300 nitrosamines are known, many of which are highly potent mutagenic carcinogens. Regulators first became aware of the presence of nitrosamines in EU medicines in 2018, with reports of detection of N-nitroso-dimethylamine (NDMA) in valsartan from one manufacturer. A subsequent EU review of all valsartan medicines was triggered by the European Medicines Agency (EMA) and was later extended to other angiotensin receptor blockers/sartans. A separate review was also started for ranitidine medicines. This was followed by an EU-wide examination of the risk of presence of nitrosamines in all human medicines. This article reflects on the investigation of the EU regulatory network into the presence of nitrosamines and the scientific knowledge informing recommendations for developers on how to limit nitrosamines in medicines.

Automated summary

Global regulators have recently taken action to investigate and limit the presence of nitrosamine impurities in human medicines, with over 300 known nitrosamines posing potential risks to patients. The European Union first detected nitrosamines in medicines in 2018, leading to reviews of specific drug classes and eventually a comprehensive assessment of the risk of nitrosamine presence in all human medicines.