Nitrosamines have been in the news since 2018, when elevated levels of nitrosamines – a probable carcinogen – were detected in several blood pressure medications. Since then, elevated levels of nitrosamines have been found in some other commonly prescribed medicines such as antacids, diabetes drugs, and smoking cessation medicines, to name a few.
Not only do nitrosamines pose a risk of physical harm to patients, but they can result in marketplace disruptions including product recalls, withdrawals, and even drug shortages. Nitrosamine impurities in medicines can also undermine trust in medicine quality, harming patients who may be reluctant to take the medicines they need to stay healthy.
Nitrosamine Drug-Substance Related Impurities (NDSRIs) have further complicated the issue, due to the lack of availability of toxicity data and acceptable intake limits, creating new challenges to keep up with.