Nitrosamine impurities in medications: Medications affected
Medication Name | Used for treating | Canadian products affected | What you should do | What we're doing |
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Acyclovir | Shingles, genital herpes | Yes Certain products recalled in Canada |
Continue taking your medication unless you have been advised to stop by your health care provider. Not treating your condition may pose a greater health risk than potential nitrosamine exposure. Talk to your health care provider if you have any questions or concerns or you want to discuss other treatments. |
We asked companies to:
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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:
Ask your pharmacist if you're not sure if the product you're taking has been recalled. |
We asked companies to:
We also:
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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:
We also:
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Nizatidine (brand name Axid) |
Ulcers of the stomach and intestines
|
Yes 2 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:
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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:
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Ranitidine | Over the counter:
Prescription:
|
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:
Ask your pharmacist if you're not sure if the product you're taking has been recalled. |
We asked companies to:
We also:
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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:
We also:
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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. |
Varenicline | Smoking cessation | 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:
Ask your pharmacist if you're not sure if the product you're taking has been recalled. |
We asked companies to:
We also:
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Orphenadrine | Muscle spasms | Yes Certain products recalled in Canada |
Consider switching to another medication. Contact your health care provider:
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We asked companies to:
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Amitriptyline | Pain, anxiety, depression | Yes Certain products recalled in Canada |
Continue taking your medication. Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Contact your health care provider:
Ask your pharmacist if you're not sure if the product you're taking has been recalled. |
We asked companies to:
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Propranolol | High blood pressure, heart-related chest pain | Yes Certain products recalled in Canada |
Continue taking your medication unless you have been advised to stop by your health care provider. Not treating a condition poses a greater health risk than potential nitrosamine exposure. Talk to your health care provider if you have any questions or concerns or you want to discuss other treatments. |
We asked companies to:
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Quinapril | High blood pressure | Yes Certain products recalled in Canada |
Continue taking your medication unless you have been advised to stop by 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 or you want to discuss other treatments. |
We asked companies to:
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