**** Health Canada Release
Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs
Health Canada has been working to address the issue of N-nitrosodimethylamine (NDMA) and similar nitrosamine impurities found in certain “sartan” angiotensin receptor blocker (ARB) blood pressure medications since 2018 and, certain ranitidine drugs more recently.
Health Canada has expanded its efforts to evaluate the potential for nitrosamines in drugs other than sartans and ranitidine, along with measures to address and prevent the impurities. Health Canada has also shared information with all Canadian drug companies on the root causes of the impurities that have been identified to date. It has requested that companies:
- review their products and manufacturing processes for the possible presence of nitrosamines;
- take any necessary measures to ensure that their products do not contain nitrosamines at levels exceeding the accepted limit;
- test products if a risk of nitrosamines is identified; and
- immediately report to Health Canada if nitrosamines are detected.
In addition to testing by companies, the Department has conducted its own testing of certain sartan and ranitidine drugs, and has developed laboratory test methods to provide validated testing options for use by industry and other regulators.
The Department has also been working in collaboration with its international partners, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Health Canada is aware that U.S. FDA testing has detected NDMA in nizatidine, a prescription drug that is chemically similar to ranitidine.
Nizatidine is sold in Canada only under the brand name Axid. In light of this information, and at Health Canada’s request, the company (Pendopharm Division of Pharmascience Inc.) has voluntarily stopped sale of this drug in Canada while it investigates the issue. Axid is not being recalled in Canada at this time.
Health Canada continues to work with companies and international partners to understand the root causes of nitrosamines in drugs. The Department will take action if a risk to Canadians is identified, and will be vigilant in informing the public of any new safety information.