Nitrosamine impurities in medications: Overview

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Background

In the summer of 2018, several medications containing the active ingredient Valsartan were recalled in Canada and elsewhere in the world. This was because the nitrosamine impurity, N-nitrosodimethylamine (NDMA), was found in the active pharmaceutical ingredient (API). APIs are the substances in pharmaceutical medications that are responsible for the beneficial health effects experienced by patients or consumers.

Since then, some other medications made by different manufacturers have been found to contain NDMA or other similar nitrosamine impurities, such as:

About nitrosamine impurities

Based primarily on animal studies, nitrosamine impurities are probable human carcinogens. This means that long-term exposure to a level above what is considered safe may increase the risk of cancer.

There is no immediate health risk associated with the use of medications containing low levels of a nitrosamine impurity. Foods such as meats, dairy products and vegetables as well as drinking water may also contain low levels of nitrosamines.

We don’t expect that a nitrosamine impurity will cause harm when exposure is at or below the acceptable level. For example, no increase in the risk of cancer is expected if exposure to the nitrosamine impurity below the acceptable level occurs every day for 70 years.

The actual health risk varies from person to person. The risk depends on several factors, such as:

Patients should always talk to their health care provider before stopping a prescribed medication. Not treating a condition may pose a greater health risk than the potential exposure to a nitrosamine impurity.

What we're doing

Health Canada recognizes that the nitrosamine impurity issue may cause concern for Canadians. Your health and safety is our top priority and we will continue to take action to address risks and inform you of new safety information.

We have created a list of all medications currently known to contain nitrosamine impurities. We will continue to update it, as needed, as more information becomes available.

As we continue to hold companies accountable for determining the root causes, we’re learning more about how nitrosamine impurities may have formed or be present in medications. In the meantime, we will continue to take action to address and prevent the presence of unacceptable levels of these impurities.

These actions may include:

As the federal regulator of health products in Canada, we also:

We share information on potential root causes of nitrosamines identified to date in medications with Canadian drug companies. We also ask the companies to:

To better understand this global issue, we are collaborating and sharing information with international regulators, such as:

We continue to work with companies and our international regulatory partners to:

We regularly communicate information on health risks, test results, recalls and other actions taken. Some of these key actions and communications include:

We will continue to update Canadians if a product is being recalled.

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