Since 2018, elevated levels of nitrosamine impurities – a probable carcinogen – have been found in some commonly prescribed medicines such as blood pressure medications, antacids, diabetes drugs, and smoking cessation medicines. Nitrosamines are in the news once again; more recent drug recalls have resulted from the detection in certain medicines of drug substance-related nitrosamine impurities, a sub-category of nitrosamines with chemical structures resembling those of active pharmaceutical ingredients.
Nitrosamines can form in a lot of different ways. To ensure drug product quality, manufacturers must properly assess the risk of nitrosamine formation in their products and further investigate any potential risks. While product recalls are concerning, this is part of the process to overcome the challenge of nitrosamines and work to eliminate them from our drug supply.
