Nitrosamine impurities in medications: medications affected blood pressure ARBs Antacid ranitidine diabetes Metformin

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

Medication Name	Indication	Are Canadian products affected?	What you should do	What we’re doing
ARBs (sartans): 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 to provide a validated test 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 in other countries. 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: 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)	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 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
Pioglitazone Hydrochloride	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 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 Test for nitrosamines if nitrosamine impurities are suspected and notify us immediately if any products contain nitrosamine 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 to provide a validated test option for industry and other regulators Collected samples from companies to conduct our own testing

Medication Name

Indication

Are Canadian products affected?

What you should do

What we’re doing

ARBs (sartans):
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 to provide a validated test 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 in other countries.

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:

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)

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 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

Pioglitazone Hydrochloride

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
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

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

We also:

Developed a laboratory test method to provide a validated test option for industry and other regulators

Collected samples from companies to conduct our own testing

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Nitrosamine impurities in medications: Medications affected

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