Nitrosamines Impurities
- Nitrosamines Impurities
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became aware of nitrosamines in medicines in mid-2018 when nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were detected in blood pressure medicines known as 'sartans'. There is a very low risk that nitrosamine impurities at the levels found in medicines could cause cancer in humans.
US FDA Guidlines on Nitrosamine Impurities
- FDA has been investigating the presence of impurities, called nitrosamines, in some types of medications.
- Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines.
- FDA, in collaboration with regulatory counterparts around the world, has set internationally-recognized acceptable daily intake limits for nitrosamines. If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate.
- Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.
- Patients taking prescription medications with potential nitrosamine impurities should not stop taking their medications. Patients should talk to their health care professionals about concerns and other treatment options.
- Consumers taking over-the-counter medications with potential nitrosamine impurities may consider using other OTC products approved for their condition.
- Find information about medications that have been recalled due to potential nitrosamine impurities on the FDA recalls webpage.
- The agency is working to determine the source of these impurities and will keep the public informed.
European Medicines Agency's Guidelines on Nitrosamines
- The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities.