Advisory - Status of ranitidine drugs in Canada

OTTAWA, ON, July 23, 2020 /CNW/ -

Summary

• Product: Over-the-counter and prescription ranitidine drugs.
• Issue: Health Canada is providing an update on the status of ranitidine drugs in Canada, including enhanced safety measures the Department is putting in place to detect an impurity called N-nitrosodimethylamine (NDMA). 
• What to do: Do not stop taking prescription ranitidine without first consulting your healthcare provider. Talk to your healthcare provider about alternatives to ranitidine if you have concerns.

Issue
Health Canada is providing an update on the status of ranitidine drugs in Canada, including enhanced safety measures the Department is putting in place to detect an impurity called N-nitrosodimethylamine (NDMA).

In September 2019, Health Canada directed companies to stop distributing ranitidine drugs in Canada as an interim, precautionary measure while it assessed the risk of NDMA detected in some drugs. Since then, companies have recalled products from the Canadian market because they contained or potentially contained NDMA above acceptable levels.

Health Canada has been evaluating the issue to identify potential causes and risk mitigation measures. Based on its evaluation, Health Canada permitted companies wishing to resume sales to do so provided they test every batch of ranitidine product before releasing it and regularly throughout its shelf life, to demonstrate that products do not contain higher than accepted levels of NDMA. Some companies resumed sales in January and February 2020.

While the root cause of NDMA in ranitidine remains unclear, Health Canada has since assessed additional information, including some evidence that suggests that levels of NDMA in ranitidine products may increase over time and when stored at higher than room temperature. In addition, some limited data suggest that NDMA may form in the body after ranitidine has been consumed, but this has not been confirmed.

As a result of its assessment of this additional information, Health Canada is now directing companies wishing to sell ranitidine products in Canada to undertake the following safety measures:

• continue to test every batch of ranitidine product before releasing it and test it regularly throughout its shelf life;
• conduct more frequent testing if NDMA is detected within a certain range below the accepted limit, to enable faster detection of any increases in NDMA;
• conduct additional testing to evaluate the potential for NDMA formation under different storage conditions (e.g., above room temperature); and
• provide all of the above test data to Health Canada, along with any information to help further evaluate the potential formation of NDMA from ranitidine in the body.

These strengthened measures will enable the Department to more actively monitor for NDMA in ranitidine products over their shelf life, and to take action as needed. They will also facilitate the collection of data to increase our understanding of NDMA formation.

Ranitidine in over-the-counter format is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine products are used to reduce stomach acid for the treatment and prevention of various conditions, such as heartburn, ulcers of the stomach and intestines, and gastroesophageal reflux disease (commonly known as GERD).

Based primarily on animal studies, NDMA is classified as a probable human carcinogen. We are all exposed to low levels of NDMA through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution.

NDMA is not expected to cause harm when ingested at low levels. For example, a person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

Health Canada continues to monitor and assess the issue of NDMA in ranitidine in collaboration with other regulators as well as industry. The Department will take action as needed and inform the public of new safety information.

What you should do

• You should not stop taking your prescription ranitidine drug unless you have spoken to your healthcare provider and obtained alternative treatment. As the health risk is associated with long-term use of a contaminated drug, not treating your condition may pose a greater health risk than potential NDMA exposure.
• Contact your healthcare provider if you have taken ranitidine and have concerns about your health, or if you have questions about alternative treatment options.
• Report any health product adverse events or complaints to Health Canada.

For more information

• Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs (2019-12-02)
• Multiple recalls of ranitidine drugs; request to stop distribution remains in place while Health Canada continues to assess NDMA 
• Health Canada assessing NDMA in ranitidine (2019-09-13)

SOURCE Health Canada

Media enquiries: Health Canada, [phone], [email protected]; Public enquiries: [phone], 1-866 225-0709, [email protected]