Health Canada Issues Important Safety Information for Ranitidine Products



Health Canada Issues Important Safety Information for Ranitidine Products


Posted: Monday November 4th, 2019

By: Pinky Mazumder

On September 13, 2019 Health Canada issued an Important Safety Information to the general public titled “Health Canada assessing NDMA in ranitidine”.  In the communication, Health Canada informed Canadians about the detection of the impurity N-nitrodimethylamine (“NDMA”) in certain marketed ranitidine drug products.  Ranitidine is available in Canada over-the-counter and by prescription.  As a result of the detection, Health Canada is collaborating with other regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency to assess the issue.  

 NDMA is a probable human carcinogen. Long-term exposure above certain levels could increase the risk of cancer.  Low levels of NDMA is commonly found in certain foods and drinking water, however low levels when ingested, is not expected to cause harm.  The detection of NDMA in ranitidine drug products is now being assessed by Health Canada.  The agency is conducting laboratory tests and gathering and sharing insight with other regulatory authorities.

On September 17, 2019 Health Canada issued a further update requesting that companies stop distributing ranitidine drugs in Canada.  Health Canada concluded that the impurity may be present in ranitidine drug products regardless of the manufacturer.  However, in addition to the stop in distribution, various companies in Canada have recalled over-the-counter and/or prescription ranitidine products where NDMA levels exceeded acceptable levels.  The recalled products are listed online and updated by Health Canada as necessary.  For more information, please see the Health Canada online communications provided below in the References section.

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References:

Health Canada assessing NDMA in ranitidine:  http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70989a-eng.php

 Additional ranitidine products recalled as a precautionary measure; request to stop distribution remains in place while Health Canada continues to assess NDMA:  http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/71029a-eng.php