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

Health Canada has been working to address the issue of N-nitrosodimethylamine (NDMA) and similar nitrosamine impurities found in certain “sartan” angiotensin receptor blocker (ARB) blood pressure medications since 2018 and, certain ranitidine drugs more recently.

Health Canada has expanded its efforts to evaluate the potential for nitrosamines in drugs other than sartans and ranitidine, along with measures to address and prevent the impurities. Health Canada has also shared information with all Canadian drug companies on the root causes of the impurities that have been identified to date. It has requested that companies:

• review their products and manufacturing processes for the possible presence of nitrosamines;
• take any necessary measures to ensure that their products do not contain nitrosamines at levels exceeding the accepted limit;
• test products if a risk of nitrosamines is identified; and
• immediately report to Health Canada if nitrosamines are detected.

In addition to testing by companies, the Department has conducted its own testing of certain sartan and ranitidine drugs, and has developed laboratory test methods to provide validated testing options for use by industry and other regulators.

The Department has also been working in collaboration with its international partners, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Health Canada is aware that U.S. FDA testing has detected NDMA in nizatidine, a prescription drug that is chemically similar to ranitidine.

Nizatidine is sold in Canada only under the brand name Axid. In light of this information, and at Health Canada’s request, the company (Pendopharm Division of Pharmascience Inc.) has voluntarily stopped sale of this drug in Canada while it investigates the issue. Axid is not being recalled in Canada at this time.

Health Canada continues to work with companies and international partners to understand the root causes of nitrosamines in drugs. The Department will take action if a risk to Canadians is identified, and will be vigilant in informing the public of any new safety information.

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.