Addressing the saga of nitrosamine contamination in drugs

Zantac

Source: © Yichuan Cao/NurPhoto/Getty Images

Scientific and regulatory progress is helping minimise the impact of mutagenic impurities

In June 2018, a potentially carcinogenic nitrosamine impurity, N-nitrosodimethylamine (NDMA), was detected in valsartan, a medication used to treat high blood pressure and heart failure. Upon investigations, nitrosamines started turning up in a many different drugs. Since then industrial scientists and regulators have been working to discover more about how these impurities form, what risks they pose, and how to avoid or minimise their formation