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): |
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: 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 |
Ulcers of the stomach and intestines |
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 |
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:
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: 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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