Nitrosamine impurities in medications: Medications affected

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

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