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Health Canada Health products

Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs

Issued December 2, 2019
What to do
Based primarily on animal studies, nitrosamine impurities are classified as a probable or possible human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. Nitrosamines are not expected to cause harm when ingested at low levels. For example, a person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer. As the health risk is associated with long-term use of a contaminated drug, Health Canada continues to underscore that people who take prescription sartan, ranitidine and nizatidine drugs affected by this issue, including recalled ranitidine and sartan drugs, should continue taking their medication until they have obtained an alternative treatment from their health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Patients should talk to their doctor or pharmacist about alternative treatment options appropriate for their health circumstances. There are many alternatives in Canada that are authorized for the same or similar uses as the affected sartans, ranitidine and nizatidine. Patients should contact their health care provider if they have taken an affected product and have concerns about their health. They can also report any health product adverse events or complaints to Health Canada.