Nitrosamine impurities in medications: Affected medications

Medications in which nitrosamine impurities have been found in Canada or in other countries:

Talk to your health care provider if you have any questions or concerns.

Medication Name	Used for treating	Are Canadian products affected?	What you should do	What we’re doing
Sartans or Angiotensin II Receptor Blockers (ARBs) valsartan, candesartan, irbesartan, losartan and olmesartan	High blood pressure	Yes Certain products recalled in Canada	Continue taking your medication unless your health care provider has advised you to stop. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Contact your health care provider: to discuss treatment options if you're using a recalled product if you have taken a recalled product and are concerned about your health Ask your pharmacist if you're not sure if the product you're taking has been recalled.	We asked companies to: Conduct risk assessments to determine if their drug products might contain nitrosamine impurities Test for nitrosamines and notify us immediately if any products contain nitrosamines at higher-than-acceptable levels Recall products that contain higher-than-acceptable levels of nitrosamines (in some cases, companies have voluntarily recalled products as a precaution, even if tests found nitrosamines within accepted limits) We also: Developed a laboratory test method, which may serve as a testing option for industry and other regulators Collected samples from companies to conduct our own testing Assessed information from companies on manufacturing processes to identify potential nitrosamine causes and mitigation measures Restricted the import of products from certain foreign manufacturers
Metformin	Type 2 diabetes (Diabetes Mellitus)	Yes Certain products recalled in Canada	You should not stop taking your medication without first discussing options with your health care provider. The risks from not having adequate diabetes treatment far outweigh any possible effects of exposure to the levels of nitrosamines found in metformin. Talk to your health care provider if you have any questions or concerns.	We asked companies to: Conduct risk assessments to determine if their drug products might contain nitrosamine impurities Test for nitrosamines and notify us immediately if any products contain nitrosamines at higher-than-acceptable levels We also: Developed a laboratory test method, which may serve as a testing option for industry and other regulators Collected samples from companies to conduct our own testing
Nizatidine (brand name Axid)	Ulcers of the stomach and intestines Gastroesophageal reflux disease (known as GERD)	Yes Two lots recalled in Canada to date	Continue taking your medication until you have obtained an alternative treatment from your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Talk to your health care provider if you have any questions or concerns.	We asked the company to: Stop distribution as an interim precautionary measure until the company provides evidence that products do not contain nitrosamines above acceptable levels Conduct risk assessments to determine if its products might contain nitrosamine impurities Test for nitrosamines and notify us immediately if any products contain nitrosamine at higher-than-acceptable levels Test for nitrosamines upon release and monitor over the shelf life, notifying us if any products contain higher than acceptable levels
Pioglitazone	Type 2 diabetes (Diabetes Mellitus)	No products recalled in Canada to date If a risk to Canadians is identified, we will take action as needed and inform Canadians	Continue taking your medication. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Talk to your health care provider if you have any questions or concerns.	We asked companies to: Conduct risk assessments to determine if their drug products might contain nitrosamine impurities Test for nitrosamines if nitrosamine impurities are suspected and notify us immediately if any products contain nitrosamine at higher-than-acceptable levels
Ranitidine	Over the counter: heart burn upset and sour stomach acid indigestion Prescription: heartburn ulcers of the stomach and intestines gastroesophageal reflux disease (known as GERD)	Yes Certain products recalled in Canada	Continue taking your prescription medication until you have obtained an alternative treatment from your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Contact your health care provider: to discuss treatment options if you're using a recalled product if you have taken a recalled product and are concerned about your health Ask your pharmacist if you're not sure if the product you're taking has been recalled.	We asked companies to: Stop distribution as an interim precautionary measure until they provide evidence that products do not contain nitrosamines above acceptable levels Conduct risk assessments to determine if their drug products might contain nitrosamine impurities Meet additional requirements to continue marketing ranitidine products and submit data to us for review Test for nitrosamines upon release and monitor over the shelf life, notifying us if any products contain higher than acceptable levels Recall products that contain higher-than-acceptable levels of nitrosamines (in some cases, companies have voluntarily recalled products as a precaution, even if tests found nitrosamines within accepted limits) We also: Developed a laboratory test method, which may serve as testing option for industry and other regulators Collected samples from companies to conduct our own testing
Rifampin	Pulmonary tuberculosis, latent tuberculosis infection	No products recalled in Canada to date If a risk to Canadians is identified, we will take action as needed and inform Canadians	Continue taking your medication. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.	We asked the company to: Conduct risk assessments to determine if their drug products might contain nitrosamine impurities Test for a new nitrosamine identified, and notify us immediately if any products contain nitrosamines at higher-than-acceptable levels We also: Issued a public advisory of an interim measure to mitigate a drug shortage issue
Priftin (rifapentine)	Latent tuberculosis infection	No products recalled in Canada to date. Priftin is not authorized for sale in Canada, but is authorized by the U.S. FDA. Priftin is being imported from the U.S. by the Public Health Agency of Canada (PHAC) and Indigenous Services Canada (ISC) under the Access to Drugs in Exceptional Circumstances regulatory pathway for the treatment of latent tuberculosis infection (LTBI). Priftin is on the List of Drugs for an Urgent Public Health Need and is only available in Canada to be used in exceptional circumstances.	Continue taking your medication and contact your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Talk to your health care provider if you have any questions or concerns.	Based on the benefit/risk assessment conducted by the Public Health Agency of Canada (PHAC), in collaboration with Indigenous Services Canada (ISC), Health Canada did not object to the release of Priftin lots containing the nitrosamine impurity above the acceptable limit as an interim measure. PHAC and ISC have notified provincial and territorial senior public health officials, Indigenous public health partners as well as a national network of tuberculosis experts. Health Canada directed the company to test for nitrosamines and notify Health Canada immediately if any products contain nitrosamines above the interim acceptable limit.
Rifadin IV (rifampin)	Various authorized uses through the Special Access Program (SAP)	No products recalled in Canada to date. Rifadin IV is not authorized for sale in Canada, but is authorized by the U.S. FDA. Rifadin IV is being imported from the U.S. under the Special Access Program (SAP). Rifadin IV is only available through the SAP.	Continue taking your medication and contact your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Talk to your health care provider if you have any questions or concerns.	Health Canada has issued risk notifications to heath care providers that have accessed Rifadin IV via SAP, going back to December 2018. Risk notifications will continue to be sent to health care providers who request Rifadin IV until the issue is resolved. Contact hc.sapd-pasm.sc@canada.ca for more information

Medication Name

Used for treating

Are Canadian products affected?

What you should do

What we’re doing

Sartans or Angiotensin II Receptor Blockers (ARBs) valsartan, candesartan, irbesartan, losartan and olmesartan

High blood pressure

Yes

Certain products recalled in Canada

Continue taking your medication unless your health care provider has advised you to stop. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

Contact your health care provider:

to discuss treatment options if you're using a recalled product
if you have taken a recalled product and are concerned about your health

Ask your pharmacist if you're not sure if the product you're taking has been recalled.

We asked companies to:

Conduct risk assessments to determine if their drug products might contain nitrosamine impurities

Test for nitrosamines and notify us immediately if any products contain nitrosamines at higher-than-acceptable levels

Recall products that contain higher-than-acceptable levels of nitrosamines (in some cases, companies have voluntarily recalled products as a precaution, even if tests found nitrosamines within accepted limits)

We also:

Developed a laboratory test method, which may serve as a testing option for industry and other regulators

Collected samples from companies to conduct our own testing

Assessed information from companies on manufacturing processes to identify potential nitrosamine causes and mitigation measures

Restricted the import of products from certain foreign manufacturers

Metformin

Type 2 diabetes (Diabetes Mellitus)

Yes

Certain products recalled in Canada

You should not stop taking your medication without first discussing options with your health care provider.

The risks from not having adequate diabetes treatment far outweigh any possible effects of exposure to the levels of nitrosamines found in metformin.

Talk to your health care provider if you have any questions or concerns.

We asked companies to:

Conduct risk assessments to determine if their drug products might contain nitrosamine impurities

Test for nitrosamines and notify us immediately if any products contain nitrosamines at higher-than-acceptable levels

We also:

Developed a laboratory test method, which may serve as a testing option for industry and other regulators

Collected samples from companies to conduct our own testing

Nizatidine
(brand name Axid)

Ulcers of the stomach and intestines

Gastroesophageal reflux disease (known as GERD)

Yes

Two lots recalled in Canada to date

Continue taking your medication until you have obtained an alternative treatment from your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

Talk to your health care provider if you have any questions or concerns.

We asked the company to:

Stop distribution as an interim precautionary measure until the company provides evidence that products do not contain nitrosamines above acceptable levels

Conduct risk assessments to determine if its products might contain nitrosamine impurities

Test for nitrosamines and
notify us immediately if any products contain nitrosamine at higher-than-acceptable levels

Test for nitrosamines upon release and monitor over the shelf life, notifying us if any products contain higher than acceptable levels

Pioglitazone

Type 2 diabetes (Diabetes Mellitus)

No products recalled in Canada to date

If a risk to Canadians is identified, we will take action as needed and inform Canadians

Continue taking your medication. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

Talk to your health care provider if you have any questions or concerns.

We asked companies to:

Conduct risk assessments to determine if their drug products might contain nitrosamine impurities

Test for nitrosamines if nitrosamine impurities are suspected and notify us immediately if any products contain nitrosamine at higher-than-acceptable levels

Ranitidine

Over the counter:

heart burn
upset and sour stomach
acid indigestion

Prescription:

heartburn
ulcers of the stomach and intestines
gastroesophageal reflux disease (known as GERD)

Yes

Certain products recalled in Canada

Continue taking your prescription medication until you have obtained an alternative treatment from your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

Contact your health care provider:

to discuss treatment options if you're using a recalled product
if you have taken a recalled product and are concerned about your health

Ask your pharmacist if you're not sure if the product you're taking has been recalled.

We asked companies to:

Stop distribution as an interim precautionary measure until they provide evidence that products do not contain nitrosamines above acceptable levels

Conduct risk assessments to determine if their drug products might contain nitrosamine impurities

Meet additional requirements to continue marketing ranitidine products and submit data to us for review

Test for nitrosamines upon release and monitor over the shelf life, notifying us if any products contain higher than acceptable levels

We also:

Developed a laboratory test method, which may serve as testing option for industry and other regulators

Collected samples from companies to conduct our own testing

Rifampin

Pulmonary tuberculosis, latent tuberculosis infection

No products recalled in Canada to date

If a risk to Canadians is identified, we will take action as needed and inform Canadians

Continue taking your medication. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

We asked the company to:

Conduct risk assessments to determine if their drug products might contain nitrosamine impurities

Test for a new nitrosamine identified, and notify us immediately if any products contain nitrosamines at higher-than-acceptable levels

We also:

Issued a public advisory of an interim measure to mitigate a drug shortage issue

Priftin (rifapentine)

Latent tuberculosis infection

No products recalled in Canada to date.

Priftin is not authorized for sale in Canada, but is authorized by the U.S. FDA. Priftin is being imported from the U.S. by the Public Health Agency of Canada (PHAC) and Indigenous Services Canada (ISC) under the Access to Drugs in Exceptional Circumstances regulatory pathway for the treatment of latent tuberculosis infection (LTBI).

Priftin is on the List of Drugs for an Urgent Public Health Need and is only available in Canada to be used in exceptional circumstances.

Continue taking your medication and contact your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

Talk to your health care provider if you have any questions or concerns.

Based on the benefit/risk assessment conducted by the Public Health Agency of Canada (PHAC), in collaboration with Indigenous Services Canada (ISC), Health Canada did not object to the release of Priftin lots containing the nitrosamine impurity above the acceptable limit as an interim measure. PHAC and ISC have notified provincial and territorial senior public health officials, Indigenous public health partners as well as a national network of tuberculosis experts.

Health Canada directed the company to test for nitrosamines and notify Health Canada immediately if any products contain nitrosamines above the interim acceptable limit.

Rifadin IV (rifampin)

Various authorized uses through the Special Access Program (SAP)

No products recalled in Canada to date.

Rifadin IV is not authorized for sale in Canada, but is authorized by the U.S. FDA. Rifadin IV is being imported from the U.S. under the Special Access Program (SAP).

Rifadin IV is only available through the SAP.

Continue taking your medication and contact your health care provider. Not treating a condition may pose a greater health risk than potential nitrosamine exposure.

Talk to your health care provider if you have any questions or concerns.

Health Canada has issued risk notifications to heath care providers that have accessed Rifadin IV via SAP, going back to December 2018. Risk notifications will continue to be sent to health care providers who request Rifadin IV until the issue is resolved.

Contact hc.sapd-pasm.sc@canada.ca for more information

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Nitrosamine impurities in medications: Affected medications

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