Health Canada Issues Important Safety Information for Ranitidine Products
Published on November 4, 2019By: 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.
Thank you for reading Regulated Affairs, the CAPRA blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Please feel free to share our blog posts and join us on social media.
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
Related Articles
Artificial Intelligence – Revolutionizing the Healthcare Industry
What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...
Technology Continues to Transform Healthcare and the Regulatory World
Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...
Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada
What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...